throbber
Nasacort Allergy 24HR 120 Sprays Carton - Outside Layout
`10.09.13
`NAS_Allergy_24HR_120_CTN_r3
`
`Original
`Original
`Prescription Strength
`Prescription Strength
`
`Original
`Prescription Strength
`
`NDC xxxxx-xxxx-x
`
`Multi-Symptom
`Nasal Allergy Spray
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`24
`
`HR
`
`Relief of:
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`120
`SPRAYS
`
`0.57 fl. oz.
`(16.9 ml)
`
`Read insert (inside package) for
`complete instructions on how to:
`Get a new bottle ready (primed)
`before first use
`Prime bottle again if not used for
`more than 2 weeks
`Use the spray
`Clean the spray nozzle
`
`BEFORE FIRST USE, A NEW BOTTLE
`MUST BE PRIMED
`
`SHAKE WELL
`BEFORE EACH USE
`
`UPC
`
`Actual Size
`
`Drug Facts
`Active ingredient (in each spray) Purpose
`Triamcinolone acetonide
` (glucocorticoid) 55 mcg............................................Nasal allergy symptom reliever
`Uses
`temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`Warnings
`Do not use
`䡲 in children under 2 years of age
`䡲 if you have ever had an allergic reaction to any of the ingredients
`Ask a doctor before use if you
`䡲 have had recent nose ulcers or nose surgery
`䡲 have had a nose injury that has not healed
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 have an eye infection
`䡲 have or had glaucoma or cataracts
`When using this product
`䡲 the growth rate of some children may be slower
`䡲 some symptoms may get better on the first day of treatment. It may take up to
` one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take, including this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox, measles or
` tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of children. In case of overdose, get medical help or contact a
`Poison Control Center right away.
`Directions
`Read insert (inside package) on how to:
`䡲 get a new bottle ready (primed) before first use
`䡲 prime bottle again if not used for more than 2 weeks
`䡲 use the spray
`䡲 clean the spray nozzle
`
`adults and
`children 12
`years of age
`and older
`
`Drug Facts (continued)
`ADULTS AND CHILDREN 12 YEARS
`OF AGE AND OLDER
`䡲 once daily, spray 2 times into
` each nostril while sniffing gently
`䡲 once your allergy symptoms
` improve, reduce to 1 spray in
` each nostril per day
`CHILDREN 2 TO UNDER 12 YEARS OF AGE
`䡲 the growth rate of some children may be
` slower while using this product. Talk to your
` child’s doctor if your child needs to use the
` spray for longer than two months a year.
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into
` each nostril while sniffing gently
`䡲 if allergy symptoms do not
` improve, increase to 2 sprays
` in each nostril per day. Once
` allergy symptoms improve,
` reduce to 1 spray in each
` nostril per day.
`
`children 6
`to under 12
`years of age
`
`children 2
`to under 6
`years of age
`
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into
` each nostril while sniffing gently
`
`䡲 do not use
`
`children
`under 2
`years of age
`䡲 do not use more than directed
`䡲 if you forget a dose, do not double the next
` dose
`䡲 do not spray into eyes or mouth
`䡲 if allergy symptoms do not improve after
` one week, stop using and talk to a doctor
`䡲 do not use for the common cold
`䡲 shake well before each use
`
`Dist. by: Chattem, Inc., a Sanofi Company
`Chattanooga, TN 37409-0219
`© 2013 Origin France
`
`000000-00
`
`Drug Facts (continued)
`Other information
`䡲 do not use if sealed package is torn or
` opened
`䡲 keep package and insert. They contain
` important information.
`䡲 store between 20°- 25° C (68°-77° F)
`
`
`
`
`
`
`
`Inactive ingredients
`benzalkonium chloride,
`carboxymethylcellulose sodium, dextrose,
`edetate disodium, hydrochloric acid or
`sodium hydroxide (for pH adjustment),
`microcrystalline cellulose, polysorbate 80,
`purified water
`Questions or comments?
` call toll-free 1-800-633-1610
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 1 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Partial Cover Clamshell - Outside Layout
`10.09.13
`NAS_Allergy_24HR_120_PC_r3
`
`Original
`Prescription Strength
`
`NDC 41167-5800-5
`
`Multi-Symptom
`Nasal Allergy Spray
`
`Drug Facts (continued)
`Inactive ingredients
`benzalkonium chloride,
`carboxymethylcellulose sodium,
`dextrose, edetate disodium,
`hydrochloric acid or sodium
`hydroxide (for pH adjustment),
`microcrystalline cellulose,
`polysorbate 80, purified water
`
`Questions or comments?
` call toll-free 1-800-633-1610
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`24
`
`HR
`
`Relief of:
`
`0.57 fl. oz.
`(16.9 ml)
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`120
`
`SPRAYS
`
`Drug Facts
`Active ingredient (in each spray) Purpose
`Triamcinolone acetonide
` (glucocorticoid) 55 mcg ................... Nasal allergy symptom reliever
`Uses
`temporarily relieves these symptoms of hay fever or other upper
`respiratory allergies:
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`Warnings
`Do not use
`䡲 in children under 2 years of age
`䡲 if you have ever had an allergic reaction to any of the ingredients
`Ask a doctor before use if you
`䡲 have had recent nose ulcers or nose surgery
`䡲 have had a nose injury that has not healed
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 have an eye infection
`䡲 have or had glaucoma or cataracts
`When using this product
`䡲 the growth rate of some children may be slower
`䡲 some symptoms may get better on the first day of treatment. It may
` take up to one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take,
`
`including this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox,
` measles or tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent
` fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of children. In case of overdose, get medical help
`or contact a Poison Control Center right away.
`
`Drug Facts (continued)
`Directions
`Read insert (inside package) on how to:
`䡲 get a new bottle ready (primed) before first use
`䡲 prime bottle again if not used for more than 2 weeks
`䡲 use the spray
`䡲 clean the spray nozzle
`ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
`adults and
`䡲 once daily, spray 2 times into each nostril while sniffing gently
`children 12
`䡲 once your allergy symptoms improve, reduce to 1 spray in
`years of age
` each nostril per day
`and older
`CHILDREN 2 TO UNDER 12 YEARS OF AGE
`䡲 the growth rate of some children may be slower while using this product.
` Talk to your child’s doctor if your child needs to use the spray for longer than
` two months a year.
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into each nostril while sniffing gently
`䡲 if allergy symptoms do not improve, increase to 2 sprays
` in each nostril per day. Once allergy symptoms improve,
` reduce to 1 spray in each nostril per day.
`
`children 6
`to under 12
`years of age
`
`䡲 do not use
`
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into each nostril while sniffing gently
`
`children 2
`to under 6
`years of age
`children
`under 2
`years of age
`䡲 do not use more than directed
`䡲 if you forget a dose, do not double the next dose
`䡲 do not spray into eyes or mouth
`䡲 if allergy symptoms do not improve after one week, stop using and talk
` to a doctor
`䡲 do not use for the common cold
`䡲 shake well before each use
`Other information
`䡲 do not use if sealed package is torn or opened
`䡲 keep package and insert. They contain important information.
`䡲 store between 20°- 25°C (68°-77°F)
`
`EXP
`
`LOT
`
`0044404-01
`
`Dist. by: Chattem, Inc.,
`a Sanofi Company
`Chattanooga, TN 37409-0219
`© 2013 Origin France
`
`UPC
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 2 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Partial Cover Clamshell - Inside Layout
`10.09.13
`NAS_Allergy_24HR_120_PC_r3
`
`Read insert (inside package)
`for complete instructions
`on how to:
`Get a new bottle ready
`(primed) before first use
`Prime bottle again if not used
`for more than 2 weeks
`Use the spray
`Clean the spray nozzle
`
`BEFORE FIRST USE,
`A NEW BOTTLE
`MUST BE PRIMED
`
`Prescription strength allergy relief.
`Without a prescription.
`
`24 hour symptom relief
`from indoor & outdoor allergies
`
`
`
`
`
`SHAKE WELL
`BEFORE EACH USE
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 3 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Partial Cover Clamshell
`3-D Rendering
`10.09.13
`NAS_Allergy_24HR_120_PC_r3
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 4 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Partial Cover Clamshell - Outside Layout
`10.09.13
`NAS_Allergy_24HR_120_PC_CPN_r3
`
`Original
`Prescription Strength
`
`NDC 41167-5800-5
`
`Multi-Symptom
`Nasal Allergy Spray
`
`Drug Facts (continued)
`Inactive ingredients
`benzalkonium chloride,
`carboxymethylcellulose sodium,
`dextrose, edetate disodium,
`hydrochloric acid or sodium
`hydroxide (for pH adjustment),
`microcrystalline cellulose,
`polysorbate 80, purified water
`
`Questions or comments?
` call toll-free 1-800-633-1610
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`24
`
`HR
`
`Relief of:
`
`0.57 fl. oz.
`(16.9 ml)
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`120
`
`SPRAYS
`
`Drug Facts
`Active ingredient (in each spray) Purpose
`Triamcinolone acetonide
` (glucocorticoid) 55 mcg ................... Nasal allergy symptom reliever
`Uses
`temporarily relieves these symptoms of hay fever or other upper
`respiratory allergies:
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`Warnings
`Do not use
`䡲 in children under 2 years of age
`䡲 if you have ever had an allergic reaction to any of the ingredients
`Ask a doctor before use if you
`䡲 have had recent nose ulcers or nose surgery
`䡲 have had a nose injury that has not healed
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 have an eye infection
`䡲 have or had glaucoma or cataracts
`When using this product
`䡲 the growth rate of some children may be slower
`䡲 some symptoms may get better on the first day of treatment. It may
` take up to one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take,
`
`including this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox,
` measles or tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent
` fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of children. In case of overdose, get medical help
`or contact a Poison Control Center right away.
`
`Drug Facts (continued)
`Directions
`Read insert (inside package) on how to:
`䡲 get a new bottle ready (primed) before first use
`䡲 prime bottle again if not used for more than 2 weeks
`䡲 use the spray
`䡲 clean the spray nozzle
`ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
`adults and
`䡲 once daily, spray 2 times into each nostril while sniffing gently
`children 12
`䡲 once your allergy symptoms improve, reduce to 1 spray in
`years of age
` each nostril per day
`and older
`CHILDREN 2 TO UNDER 12 YEARS OF AGE
`䡲 the growth rate of some children may be slower while using this product.
` Talk to your child’s doctor if your child needs to use the spray for longer than
` two months a year.
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into each nostril while sniffing gently
`䡲 if allergy symptoms do not improve, increase to 2 sprays
` in each nostril per day. Once allergy symptoms improve,
` reduce to 1 spray in each nostril per day.
`
`children 6
`to under 12
`years of age
`
`䡲 do not use
`
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into each nostril while sniffing gently
`
`children 2
`to under 6
`years of age
`children
`under 2
`years of age
`䡲 do not use more than directed
`䡲 if you forget a dose, do not double the next dose
`䡲 do not spray into eyes or mouth
`䡲 if allergy symptoms do not improve after one week, stop using and talk
` to a doctor
`䡲 do not use for the common cold
`䡲 shake well before each use
`Other information
`䡲 do not use if sealed package is torn or opened
`䡲 keep package and insert. They contain important information.
`䡲 store between 20°- 25°C (68°-77°F)
`
`EXP
`
`LOT
`
`0044308-01
`
`Dist. by: Chattem, Inc.,
`a Sanofi Company
`Chattanooga, TN 37409-0219
`© 2013 Origin France
`
`UPC
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 5 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Partial Cover Clamshell - Inside Layout with Coupon
`10.09.13
`NAS_Allergy_24HR_120_PC_CPN_r3
`
`Prescription strength allergy relief.
`Without a prescription.
`
`24 hour symptom relief
`from indoor & outdoor allergies
`
`Read insert (inside package)
`for complete instructions
`on how to:
`Get a new bottle ready
`(primed) before first use
`Prime bottle again if not used
`for more than 2 weeks
`Use the spray
`Clean the spray nozzle
`
`BEFORE FIRST USE,
`A NEW BOTTLE
`MUST BE PRIMED
`
`MANUFACTURER’S COUPON EXPIRATION DATE XX/XX/XX
`
`
`
`SAVE $X.XXSAVE $X.XX
`
`On your next purchase of any size Nasacort® Allergy 24HR Spray
`READ THE PRODUCT LABELING TO DETERMINE IF THIS PRODUCT
`IS APPROPRIATE FOR YOU TO USE. USE ONLY AS DIRECTED.
`COUPON CANNOT BE COMBINED WITH OTHER COUPONS.
`Consumer: Limit one coupon per transaction. Good only in the U.S.
`and overseas commissaries on the purchase of the specified
`product/size. Void where prohibited or if altered, copied,
`transferred, auctioned, or sold. You must pay sales tax. Cash value:
`1/100 of 1¢. Retailer: We will reimburse you for the face value of
`this coupon plus 8¢ if redeemed in compliance with our Coupon
`Reimbursement Policy (available at address below). Invoices
`proving purchase of sufficient stock to cover coupons presented for
`redemption must be provided upon request. Failure to follow the
`policy may constitute fraud and may void all coupons submitted.
`Mail to: Chattem, Inc., PO Box 880445, El Paso, TX 88588-0445.
`Use only as directed.
`
`
`
`FPO
`
`SHAKE WELL
`BEFORE EACH USE
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 6 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Carton - Outside Layout
`10.09.13
`NAS_Allergy_24HR_120_CTN_CPN_r3
`
`Original
`Original
`Prescription Strength
`Prescription Strength
`
`Original
`Prescription Strength
`
`NDC xxxxx-xxxx-x
`
`Multi-Symptom
`Nasal Allergy Spray
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`24
`
`HR
`
`Relief of:
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`120
`SPRAYS
`
`0.57 fl. oz.
`(16.9 ml)
`
`Read insert (inside package) for
`complete instructions on how to:
`Get a new bottle ready (primed)
`before first use
`Prime bottle again if not used for
`more than 2 weeks
`Use the spray
`Clean the spray nozzle
`
`BEFORE FIRST USE, A NEW BOTTLE
`MUST BE PRIMED
`
`SHAKE WELL
`BEFORE EACH USE
`
`UPC
`
`Actual Size
`
`Drug Facts
`Active ingredient (in each spray) Purpose
`Triamcinolone acetonide
` (glucocorticoid) 55 mcg............................................Nasal allergy symptom reliever
`Uses
`temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`Warnings
`Do not use
`䡲 in children under 2 years of age
`䡲 if you have ever had an allergic reaction to any of the ingredients
`Ask a doctor before use if you
`䡲 have had recent nose ulcers or nose surgery
`䡲 have had a nose injury that has not healed
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 have an eye infection
`䡲 have or had glaucoma or cataracts
`When using this product
`䡲 the growth rate of some children may be slower
`䡲 some symptoms may get better on the first day of treatment. It may take up to
` one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take, including this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox, measles or
` tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of children. In case of overdose, get medical help or contact a
`Poison Control Center right away.
`Directions
`Read insert (inside package) on how to:
`䡲 get a new bottle ready (primed) before first use
`䡲 prime bottle again if not used for more than 2 weeks
`䡲 use the spray
`䡲 clean the spray nozzle
`
`adults and
`children 12
`years of age
`and older
`
`Drug Facts (continued)
`ADULTS AND CHILDREN 12 YEARS
`OF AGE AND OLDER
`䡲 once daily, spray 2 times into
` each nostril while sniffing gently
`䡲 once your allergy symptoms
` improve, reduce to 1 spray in
` each nostril per day
`CHILDREN 2 TO UNDER 12 YEARS OF AGE
`䡲 the growth rate of some children may be
` slower while using this product. Talk to your
` child’s doctor if your child needs to use the
` spray for longer than two months a year.
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into
` each nostril while sniffing gently
`䡲 if allergy symptoms do not
` improve, increase to 2 sprays
` in each nostril per day. Once
` allergy symptoms improve,
` reduce to 1 spray in each
` nostril per day.
`
`children 6
`to under 12
`years of age
`
`children 2
`to under 6
`years of age
`
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into
` each nostril while sniffing gently
`
`䡲 do not use
`
`children
`under 2
`years of age
`䡲 do not use more than directed
`䡲 if you forget a dose, do not double the next
` dose
`䡲 do not spray into eyes or mouth
`䡲 if allergy symptoms do not improve after
` one week, stop using and talk to a doctor
`䡲 do not use for the common cold
`䡲 shake well before each use
`
`Dist. by: Chattem, Inc., a Sanofi Company
`Chattanooga, TN 37409-0219
`© 2013 Origin France
`
`000000-00
`
`Drug Facts (continued)
`Other information
`䡲 do not use if sealed package is torn or
` opened
`䡲 keep package and insert. They contain
` important information.
`䡲 store between 20°- 25° C (68°-77° F)
`
`
`
`
`
`
`
`Inactive ingredients
`benzalkonium chloride,
`carboxymethylcellulose sodium, dextrose,
`edetate disodium, hydrochloric acid or
`sodium hydroxide (for pH adjustment),
`microcrystalline cellulose, polysorbate 80,
`purified water
`Questions or comments?
` call toll-free 1-800-633-1610
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 7 of 39
`
`

`

`Nasacort Allergy 24HR 120 Sprays Carton - Inside with On-Pack Coupon
`10.09.13
`NAS_Allergy_24HR_120_CTN_CPN_r3
`
`VALUABLE
`COUPON INSIDE!
`
`Use only as directed. © 2013 Chattem, Inc.
`
`coupons submitted. Mail to: Chattem, Inc., PO Box 880445, El Paso, TX 88588-0445.
`provided upon request. Failure to follow the policy may constitute fraud and may void all
`proving purchase of sufficient stock to cover coupons presented for redemption must be
`compliance with our Coupon Reimbursement Policy (available at address below). Invoices
`1¢. Retailer: We will reimburse you for the face value of this coupon plus 8¢ if redeemed in
`altered, copied, transferred, auctioned, or sold. You must pay sales tax. Cash value: 1/100 of
`commissaries on the purchase of the specified product/size. Void where prohibited or if
`Consumer: Limit one coupon per transaction. Good only in the U.S. and overseas
`TO USE. USE ONLY AS DIRECTED. COUPON CANNOT BE COMBINED WITH OTHER COUPONS.
`READ THE PRODUCT LABELING TO DETERMINE IF THIS PRODUCT IS APPROPRIATE FOR YOU
`
`MANUFACTURER’S COUPON EXPIRATION DATE XX/XX/XX
`
`SAVE $X.XX
`SAVE $X.XX
`
`On your next purchase of any size Nasacort® Allergy 24HR Spray.
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 8 of 39
`
`

`

`NAS ALLERGY 24HR 2X120 CLUB - Front
`10.9.13
`NAS_ALG_2X120_CLUB_r3
`
`NDC 41167-XXXX-X
`
`Original
`Prescription Strength
`
`Multi-Symptom
`Nasal Allergy Spray
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`2 x 120
`
`SPRAYS
`
`0044312-01
`
`24HR
`
`Relief of:
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`Total spray count 240
`Each bottle contains
`0.57 fl. oz. (16.9 ml)
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 9 of 39
`
`

`

`NAS ALLERGY 24HR 2X120 CLUB - Back
`10.9.13
`NAS_ALG_2X120_CLUB_r3
`
`LOT XXXXXXX
`
`EXP MM/YYYY
`
`children 6 to under
`12 years of age
`
`Drug Facts
`Drug Facts (continued)
`Directions
`Active ingredient (in each spray) Purpose
`Read insert (inside package) on how to:
`Triamcinolone acetonide
`Nasal allergy
`䡲 get a new bottle ready (primed) before first use
` (glucocorticoid) 55 mcg.....................................................symptom reliever
`䡲 prime bottle again if not used for more than 2 weeks
`䡲 use the spray
`Uses
`䡲 clean the spray nozzle
`temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
`ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`adults and
`䡲 once daily, spray 2 times into each nostril while sniffing gently
`Warnings
`children 12 years
`䡲 once your allergy symptoms improve, reduce to 1 spray
`Do not use
`in each nostril per day
`of age and older
`䡲 in children under 2 years of age
`CHILDREN 2 TO UNDER 12 YEARS OF AGE
`䡲 if you have ever had an allergic reaction to any of the ingredients
`䡲 the growth rate of some children may be slower while using this product.
`Ask a doctor before use if you
`Talk to your child’s doctor if your child needs to use the spray for longer
`䡲 have had recent nose ulcers or nose surgery
`than two months a year.
`䡲 have had a nose injury that has not healed
`䡲 an adult should supervise use
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 once daily, spray 1 time into each nostril while sniffing gently
`䡲 have an eye infection
`䡲 if allergy symptoms do not improve, increase to 2
`䡲 have or had glaucoma or cataracts
`sprays in each nostril per day. Once allergy symptoms
`improve, reduce to 1 spray in each nostril per day.
`When using this product
`䡲 an adult should supervise use
`䡲 the growth rate of some children may be slower
`䡲 once daily, spray 1 time into each nostril while sniffing gently
`䡲 some symptoms may get better on the first day of treatment. It may take
`up to one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take, including
`this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox,
`measles or tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of children. In case of overdose, get medical help or
`contact a Poison Control Center right away.
`
`䡲 do not use
`
`children 2 to under
`6 years of age
`children under 2
`years of age
`䡲 do not use more than directed
`䡲 if you forget a dose, do not double the next dose
`䡲 do not spray into eyes or mouth
`䡲 if allergy symptoms do not improve after one week, stop using and talk to a doctor
`䡲 do not use for the common cold
`䡲 shake well before each use
`Other information
`䡲 do not use if sealed package is torn or opened
`䡲 keep package and insert. They contain important information.
`䡲 store between 20°-25°C (68°-77°F)
`Inactive ingredients
`benzalkonium chloride, carboxymethylcellulose sodium, dextrose, edetate
`disodium, hydrochloric acid or sodium hydroxide (for pH adjustment),
`microcrystalline cellulose, polysorbate 80, purified water
`Questions or comments? call toll-free 1-800-633-1610
`
`UPC
`
`Dist. by: Chattem, Inc., a Sanofi Company
`Chattanooga, TN 37409-0219 © 2013
`Origin France 0044314-01
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 10 of 39
`
`

`

`Nasacort Allergy 24HR 30 Sprays Carton - Outside Layout
`10.09.13
`NAS_Allergy_24HR_30_CTN_CPN_r3
`
`Read insert (inside package) for
`complete instructions on how to:
`Get a new bottle ready (primed)
`before first use
`Prime bottle again if not used for
`more than 2 weeks
`Use the spray
`Clean the spray nozzle
`
`BEFORE FIRST USE, A NEW BOTTLE
`MUST BE PRIMED
`
`SHAKE WELL
`BEFORE EACH USE
`
`UPC
`
`Actual Size
`
`Original
`Original
`Prescription Strength
`Prescription Strength
`
`Original
`Prescription Strength
`
`NDC xxxxx-xxxx-x
`
`Multi-Symptom
`Nasal Allergy Spray
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`24
`
`HR
`
`Relief of:
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`30
`SPRAYS
`
`0.23 fl. oz.
`(6.7 ml)
`
`Drug Facts
`Active ingredient (in each spray) Purpose
`Triamcinolone acetonide
` (glucocorticoid) 55 mcg............................................Nasal allergy symptom reliever
`Uses
`temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`Warnings
`Do not use
`䡲 in children under 2 years of age
`䡲 if you have ever had an allergic reaction to any of the ingredients
`Ask a doctor before use if you
`䡲 have had recent nose ulcers or nose surgery
`䡲 have had a nose injury that has not healed
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 have an eye infection
`䡲 have or had glaucoma or cataracts
`When using this product
`䡲 the growth rate of some children may be slower
`䡲 some symptoms may get better on the first day of treatment. It may take up to
` one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take, including this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox, measles or
` tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of children. In case of overdose, get medical help or contact a
`Poison Control Center right away.
`Directions
`Read insert (inside package) on how to:
`䡲 get a new bottle ready (primed) before first use
`䡲 prime bottle again if not used for more than 2 weeks
`䡲 use the spray
`䡲 clean the spray nozzle
`
`adults and
`children 12
`years of age
`and older
`
`Drug Facts (continued)
`ADULTS AND CHILDREN 12 YEARS
`OF AGE AND OLDER
`䡲 once daily, spray 2 times into
` each nostril while sniffing gently
`䡲 once your allergy symptoms
` improve, reduce to 1 spray in
` each nostril per day
`CHILDREN 2 TO UNDER 12 YEARS OF AGE
`䡲 the growth rate of some children may be
` slower while using this product. Talk to your
` child’s doctor if your child needs to use the
` spray for longer than two months a year.
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into
` each nostril while sniffing gently
`䡲 if allergy symptoms do not
` improve, increase to 2 sprays
` in each nostril per day. Once
` allergy symptoms improve,
` reduce to 1 spray in each
` nostril per day.
`
`children 6
`to under 12
`years of age
`
`children 2
`to under 6
`years of age
`
`䡲 an adult should supervise use
`䡲 once daily, spray 1 time into
` each nostril while sniffing gently
`
`䡲 do not use
`
`children
`under 2
`years of age
`䡲 do not use more than directed
`䡲 if you forget a dose, do not double the next
` dose
`䡲 do not spray into eyes or mouth
`䡲 if allergy symptoms do not improve after
` one week, stop using and talk to a doctor
`䡲 do not use for the common cold
`䡲 shake well before each use
`
`Dist. by: Chattem, Inc., a Sanofi Company
`Chattanooga, TN 37409-0219
`© 2013 Origin France
`
`Drug Facts (continued)
`Other information
`䡲 do not use if sealed package is torn or
` opened
`䡲 keep package and insert. They contain
` important information.
`䡲 store between 20°- 25° C (68°-77° F)
`
`
`
`
`
`
`
`Inactive ingredients
`benzalkonium chloride,
`carboxymethylcellulose sodium, dextrose,
`edetate disodium, hydrochloric acid or
`sodium hydroxide (for pH adjustment),
`microcrystalline cellulose, polysorbate 80,
`purified water
`Questions or comments?
` call toll-free 1-800-633-1610
`
`PROFESSIONAL SAMPLE - NOT FOR RETAIL SALE
`
`000000-00
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 11 of 39
`
`

`

`Nasacort Allergy 24HR 30 Sprays Carton - Inside with On-Pack Coupon
`10.09.13
`NAS_Allergy_24HR_30_CTN_CPN_r3
`
`VALUABLE
`COUPON INSIDE!
`
`Use only as directed. © 2013 Chattem, Inc.
`
`coupons submitted. Mail to: Chattem, Inc., PO Box 880445, El Paso, TX 88588-0445.
`provided upon request. Failure to follow the policy may constitute fraud and may void all
`proving purchase of sufficient stock to cover coupons presented for redemption must be
`compliance with our Coupon Reimbursement Policy (available at address below). Invoices
`1¢. Retailer: We will reimburse you for the face value of this coupon plus 8¢ if redeemed in
`altered, copied, transferred, auctioned, or sold. You must pay sales tax. Cash value: 1/100 of
`commissaries on the purchase of the specified product/size. Void where prohibited or if
`Consumer: Limit one coupon per transaction. Good only in the U.S. and overseas
`TO USE. USE ONLY AS DIRECTED. COUPON CANNOT BE COMBINED WITH OTHER COUPONS.
`READ THE PRODUCT LABELING TO DETERMINE IF THIS PRODUCT IS APPROPRIATE FOR YOU
`
`MANUFACTURER’S COUPON EXPIRATION DATE XX/XX/XX
`
`SAVE $X.XX
`SAVE $X.XX
`
`On your next purchase of any size Nasacort® Allergy 24HR Spray.
`
`Reference ID: 3389317
`
`Nalox1245
`Nalox-1 Pharmaceuticals, LLC
`Page 12 of 39
`
`

`

`Nasacort Allergy 24HR 30 Sprays Carton - Outside Layout
`10.09.13
`NAS_Allergy_24HR_30_CTN_r3
`
`Read insert (inside package) for
`complete instructions on how to:
`Get a new bottle ready (primed)
`before first use
`Prime bottle again if not used for
`more than 2 weeks
`Use the spray
`Clean the spray nozzle
`
`BEFORE FIRST USE, A NEW BOTTLE
`MUST BE PRIMED
`
`SHAKE WELL
`BEFORE EACH USE
`
`UPC
`
`Actual Size
`
`Original
`Original
`Prescription Strength
`Prescription Strength
`
`Original
`Prescription Strength
`
`NDC xxxxx-xxxx-x
`
`Multi-Symptom
`Nasal Allergy Spray
`
`triamcinolone acetonide (glucocorticoid)
`55 mcg per spray/Nasal Allergy Symptom Reliever
`
`24
`
`HR
`
`Relief of:
`
`Nasal Congestion
`Sneezing
`Runny Nose
`Itchy Nose
`
`30
`SPRAYS
`
`0.23 fl. oz.
`(6.7 ml)
`
`Drug Facts
`Active ingredient (in each spray) Purpose
`Triamcinolone acetonide
` (glucocorticoid) 55 mcg............................................Nasal allergy symptom reliever
`Uses
`temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
`䡲 nasal congestion 䡲 runny nose 䡲 sneezing 䡲 itchy nose
`Warnings
`Do not use
`䡲 in children under 2 years of age
`䡲 if you have ever had an allergic reaction to any of the ingredients
`Ask a doctor before use if you
`䡲 have had recent nose ulcers or nose surgery
`䡲 have had a nose injury that has not healed
`䡲 are using a steroid medicine for asthma, allergies or skin rash
`䡲 have an eye infection
`䡲 have or had glaucoma or cataracts
`When using this product
`䡲 the growth rate of some children may be slower
`䡲 some symptoms may get better on the first day of treatment. It may take up to
` one week of daily use to feel the most symptom relief.
`䡲 do not share this bottle with anyone else as this may spread germs
`䡲 remember to tell your doctor about all the medicines you take, including this one
`Stop use and ask a doctor if
`䡲 you have, or come into contact with someone who has, chickenpox, measles or
` tuberculosis
`䡲 you have or develop symptoms of an infection such as a persistent fever
`䡲 you have any change in vision
`䡲 you have severe or frequent nosebleeds
`If pregnant or breast-feeding, ask a health professional before use.
`Keep out of reach of childre

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket