`
`
` CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209089Orig1s000
` 209090Orig1s000
`
`LABELING
`
`

`

`Xyzal Allergy 24 Hour Tablet Blister Carton
`01.06.17
`Xyzal_Allergy 10ct_CTN_2016_r5_CLEAN
`
`CLINICALLY PROVEN RELIEF
`IN 60 MINUTES
`
`NDC 41167-3510-0
`
`CLINICALLY PROVEN RELIEF
`
`FOR 24 HOURS
`
`The trade dress of this
`Xyzal® package is subject
`to trademark protection.
`
`Dist. By: Chattem, Inc.,
`a Sanofi Company,
`Chattanooga, TN
`37409-0219 ©2017
`
`Origin: Switzerland
`
`50122365
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
` 5 mg / antihistamine
`
`24
`
`HOUR
`RELIEF OF
`
`1010TABLETS
`
`TABLETS
`
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`LOT:
`
`EXP:
`
`CLINICALLY PROVEN RELIEF FROM
`INDOOR AND OUTDOOR ALLERGIES
`
`UPC FPO
`
`Drug Facts
`Active ingredient Purpose
`(in each tablet)
`Levocetirizine dihydrochloride 5 mg.....Antihistamine
` Uses
`temporarily relieves these symptoms due to hay
`fever or other respiratory allergies:
`䡲 runny nose 䡲 itchy, watery eyes
`䡲 sneezing 䡲 itching of the nose or throat
`Warnings
`Do not use
`䡲 if you have kidney disease
`䡲 if you have ever had an allergic reaction to this
` product or any of its ingredients or to an
` antihistamine containing cetirizine
`
`Ask a doctor before use if you have
`䡲 ever had trouble urinating or emptying your
` bladder
`
`When using this product
`䡲 drowsiness may occur
`䡲 avoid alcoholic drinks
`䡲 alcohol, sedatives, and tranquilizers may
` increase drowsiness
`䡲 be careful when driving a motor vehicle or
` operating machinery
`
`Stop use and ask a doctor if
`䡲 you have trouble urinating or emptying your
` bladder
`䡲 an allergic reaction to this product occurs.
` Seek medical help right away.
`
`If pregnant or breast-feeding:
`䡲 if breast-feeding: not recommended
`䡲 if pregnant: 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 (1-800-222-1222).
`
`䊳
`
`Drug Facts (continued)
`Directions
`adults 65 years
`of age and older
`
`䡲 ask a doctor
`
`adults and
`children 12-64
`years of age
`
`children 6-11
`years of age
`
`䡲 take 1 tablet (5 mg)
` once daily in the evening
`䡲 do not take more than
` 1 tablet (5 mg) in
` 24 hours
`䡲 ½ tablet (2.5 mg)
` once daily in the evening
` may be appropriate for
` less severe symptoms
`
`䡲 take ½ tablet (2.5 mg)
` once daily in the evening
`䡲 do not take more than
` ½ tablet (2.5 mg) in
` 24 hours
`
`children under
`6 years of age
`
`䡲 do not use
`
`䡲 do not use
`
`consumers w th
`kidney disease
`Other information
`䡲 store between 20° and 25°C
` (68° and 77°F)
`䡲 safety sealed: do not use if carton was
` opened or if individual blister unit is
` open or torn
`Inactive ingredients
`colloidal anhydrous silica, hypromellose,
`lactose monohydrate, magnesium
`stearate, microcrystalline cellulose,
`polyethylene glycol 400, titanium dioxide
`Questions or comments?
`call 1-800-630-1610
`
`Read directions and warnings before use. Keep this carton. It has important information.
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Tablet Blister
`1.03.17
`Xyzal_Allergy 10ct_PeelPush Blister_2016_r1_CLEAN
`
`Lot. Exp.
`
`Chattanooga, TN 37409
`Dist. By: Chattem, Inc.
`
`tablet 5 mg / antihistamine
`levocetirizine dihydrochloride
`ALLERGY24HR
`®
`
`Push
`Peel &
`
`P eel &
`P ush
`
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride
`tablet 5 mg / antihistamine
`
`Dist. By: Chattem, Inc.
`Chattanooga, TN 37409
`
`Lot. Exp.
`
`Lot. Exp.
`
`Chattanooga, TN 37409
`Dist. By: Chattem, Inc.
`
`tablet 5 mg / antihistamine
`levocetirizine dihydrochloride
`ALLERGY24HR
`®
`
`Push
`Peel &
`
`Lot. Exp.
`
`Chattanooga, TN 37409
`Dist. By: Chattem, Inc.
`
`tablet 5 mg / antihistamine
`levocetirizine dihydrochloride
`ALLERGY24HR
`®
`
`Push
`Peel &
`
`Push
`Peel &
`
`Lot. Exp.
`
`Chattanooga, TN 37409
`Dist. By: Chattem, Inc.
`
`tablet 5 mg / antihistamine
`levocetirizine dihydrochloride
`ALLERGY24HR
`®
`
`®
`
`ALLERGY 24HR
`
`50122369
`
`P eel &
`P ush
`
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride
`tablet 5 mg / antihistamine
`
`Dist. By: Chattem, Inc.
`Chattanooga, TN 37409
`
`Lot. Exp.
`
`P eel &
`P ush
`
`
`®®
`ALLERGY 24HR
`levocetirizine dihydrochloride
`tablet 5 mg / antihistamine
`
`Dist. By: Chattem, Inc.
`Chattanooga, TN 37409
`
`Lot. Exp.
`
`P eel &
`P ush
`
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride
`tablet 5 mg / antihistamine
`
`Dist. By: Chattem, Inc.
`Chattanooga, TN 37409
`
`Lot. Exp.
`
`P eel &
`P ush
`
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride
`tablet 5 mg / antihistamine
`
`Dist. By: Chattem, Inc.
`Chattanooga, TN 37409
`
`Lot. Exp.
`
`P eel &
`P ush
`
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride
`tablet 5 mg / antihistamine
`
`Dist. By: Chattem, Inc.
`Chattanooga, TN 37409
`
`Lot. Exp.
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Carton
`01.06.17
`Xyzal_Allergy_35ct_CTN_2016_r3_CLEAN
`
`Drug Facts (cont nued)
`Other information
`䡲 s ore be ween 20° and
` 25°C (68° and 77°F)
`䡲 safety sealed: do not use
` if carton was opened or f
` pr n ed foil inner seal on
` bott e is torn or missing
`Inactive ingredients
`co loidal anhydrous sil ca
`hypromel ose lactose
`monohydrate magnesium
`stearate microcrystall ne
`ce lulose po yethylene
`g ycol 400 itan um dioxide
`Questions or
`comments?
`ca l 1 800 633 1610
`
`Read direct ons and warn ngs
`be ore use Keep his car on
`t has important informat on
`
`NDC 41167 3510 1
`
`ORIGINAL
`ORIGINAL
`PRESCRIPTION STRENGTH
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
` 5 mg / antihistamine
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`
`Drug Facts
`Active ingredient Purpose
`(in each tablet)
`Levocetir zine d hydrochloride 5 mg
`Ant h s amine
`Uses
`emporari y re ieves these symptoms due to hay
`ever or o her respi atory allergies:
`䡲 runny nose 䡲 tchy watery eyes
`䡲 sneez ng
` 䡲 tching of the nose or throat
`Warnings
`Do not use
`䡲 if you have k dney disease
`䡲 if you have ever had an al ergic react on to this
`
` p oduct or any of ts ing edients or o an
` ant histamine containing cet rizine
`
`Ask a doctor before use if you have
`䡲 ever had trouble urina ing or emptying your
`
` b adder
`
`When using this product
`䡲 d owsiness may occur
`䡲 avoid alcoho ic drinks
`䡲 a cohol sedatives and tranqu l zers may ncrease
` drowsiness
`䡲 be care ul when dr v ng a motor veh c e or
` operat ng machinery
`
`Drug Facts (continued)
`If pregnant or breast feed ng:
`䡲 if breast feed ng: not recommended
`䡲 if pregnant: ask a heal h professional
`
` before use
`Keep out of reach of children.
`In case of overdose get med cal help or
`con act a Po son Con rol Cen er right away
`(1 800 222 1222)
`Directions
`adults 65
`years of age
`and older
`
`䡲 ask a doctor
`
`adults and
`chi d en
`12 64 years
`of age
`
`chi d en 6 11
`years of age
`
`䡲 take 1 tablet (5 mg)
`
` once dai y in the evening
`䡲 do not take more than 1
` tablet (5 mg) in 24 hours
`䡲 ½ tab et (2 5 mg) once
` dai y in the evening may
` be appropriate for ess
` severe symptoms
`
`䡲 take ½ ablet (2 5 mg)
`
` once dai y in the evening
`䡲 do not take more than ½
` tablet (2 5 mg) in 24 hours
`
`CLINICALLY PROVEN RELIEF
`
`FOR 24 HOURS
`
`CLINICALLY PROVEN RELIEF
`IN 60 MINUTES
`
`Stop use and ask a doc or f
`䡲 you have trouble ur nat ng or emptying your
`
` b adder
`䡲 an al ergic react on to this product occurs Seek
`
` medical he p r ght away
`
`chi d en under
`6 years of age
`
`䡲 do not use
`
`consumers with
`k dney d sease
`
`䊳
`
`䡲 do not use
`
`LOT
`
`EXP
`
`UPC
`FPO
`
`Reference ID 4048999
`
`The t ade dress of this Xyzal® package
` is subject to trademark protec ion
`
`Dist By Chattem Inc a Sanofi Company
`Cha tanooga TN 37409 0219
`
`©2017 Origin Sw tzerland
`
`24
`
`HOUR
`RELIEF OF
`
`䊳
`
`0100066 01
`
`TABLETS3535
`
`TABLETS
`
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`Clinically Proven 24 Hour Relief of
`Indoor and Outdoor Allergies
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Label
`01.06.17
`Xyzal_Allergy_35ct_Label_2016_r5_CLEAN
`
`DATA
`MATRIX
`CODE
`FPO
`0100141-01
`Dist. By: Chattem, Inc.,
`a Sanofi Company,
`Chattanooga, TN 37409-0219
`©2017 Origin: Switzerland
`
`24
`
`HOUR
`RELIEF OF
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`NDC 41167 3510 1
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS3535
`
`TABLETS
`
`PEEL HERE
`
`䊳
`
`Active ingredient (in each tablet) Purpose
`Levocetirizine dihydrochloride 5 mg.............................Antihistamine
`Uses temporar ly relieves these symptoms due to hay fever or other
`respiratory allergies: 䡲 runny nose 䡲 sneezing 䡲 itchy, watery eyes
`䡲 itching of the nose or throat Warnings Do not use 䡲 if you have
`kidney disease 䡲 if you have ever had an allergic reaction to this
`product or any of its ingredients or to an antihistamine containing
`cetirizine Ask a doctor before use if you have 䡲 ever had trouble
`urinating or emptying your bladder When using this product
`䡲 drowsiness may occur 䡲 avoid alcoholic drinks 䡲 alcohol,
`
`䊳
`
`sedatives, and tranquilizers may increase drowsiness 䡲 be careful when
`driving a motor vehicle or operating machinery Stop use and ask a
`doctor if 䡲 you have trouble urinating or emptying your bladder 䡲 an
`allergic reaction to this product occurs. Seek medical help right away.
`If pregnant or breast-feeding: 䡲 if breast-feeding: not recommended
`䡲 if pregnant: 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 (1-800-222-1222). Directions adults 65
`years of age and older 䡲 ask a doctor adults and children 12-64
`䊳
`years of age 䡲 take 1 tablet (5 mg) once daily in the evening
`
`NDC 41167 3510 1
`
`©2017 Origin: Swizerland
`Chattanooga, TN 37409-0219
`a Sanofi Company,
`Dist. By: Chattem, Inc.,
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS3535
`
`TABLETS
`
`䡲 do not take more than 1 tablet (5 mg) in 24 hours 䡲 ½ tablet (2.5 mg) once
`daily in the evening may be appropriate for less severe symptoms children
`6-11 years of age 䡲 take ½ tablet (2.5 mg) once daily in the evening 䡲 do
`not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of
`age 䡲 do not use consumers with kidney disease 䡲 do not use Other
`information 䡲 store between 20º and 25º C (68º and 77º F) 䡲 safety sealed:
`do not use f carton was opened or if printed foil inner seal on bottle is torn or
`missing Inactive ingredients colloidal anhydrous si ica, hypromellose, lactose
`monohydrate, magnesium stearate, microcrystal ine cellulose, polyethylene
`glycol 400, t tanium dioxide Questions or comments? call 1-800-633-1610
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Bonus Carton
`01.06.17
`Xyzal_Allergy_45ct_Bonus_CTN_2016_r4_CLEAN
`
`Drug Facts
`Active ingredient Purpose
`(in each tablet)
`Levocetir zine d hydrochloride 5 mg
`Ant h s amine
`Uses
`emporari y re ieves these symptoms due to hay
`ever or o her respi atory allergies:
`䡲 runny nose 䡲 tchy watery eyes
`䡲 sneez ng
` 䡲 tching of the nose or throat
`Warnings
`Do not use
`䡲 if you have k dney disease
`䡲 if you have ever had an al ergic react on to this
`
` p oduct or any of ts ing edients or o an
` ant histamine containing cet rizine
`
`Ask a doctor before use if you have
`䡲 ever had trouble urina ing or emptying your
`
` b adder
`
`When using this product
`䡲 d owsiness may occur
`䡲 avoid alcoho ic drinks
`䡲 a cohol sedatives and tranqu l zers may ncrease
` drowsiness
`䡲 be care ul when dr v ng a motor veh c e or
` operat ng machinery
`
`Drug Facts (continued)
`If pregnant or breast feed ng:
`䡲 if breast feed ng: not recommended
`䡲 if pregnant: ask a heal h professional
`
` before use
`Keep out of reach of children.
`In case of overdose get med cal help or
`con act a Po son Con rol Cen er right away
`(1 800 222 1222)
`Directions
`adults 65
`years of age
`and older
`
`䡲 ask a doctor
`
`adults and
`chi d en
`12 64 years
`of age
`
`chi d en 6 11
`years of age
`
`䡲 take 1 tablet (5 mg)
`
` once dai y in the evening
`䡲 do not take more than 1
` tablet (5 mg) in 24 hours
`䡲 ½ tab et (2 5 mg) once
` dai y in the evening may
` be appropriate for ess
` severe symptoms
`
`䡲 take ½ ablet (2 5 mg)
`
` once dai y in the evening
`䡲 do not take more than ½
` tablet (2 5 mg) in 24 hours
`
`CLINICALLY PROVEN RELIEF
`
`FOR 24 HOURS
`
`CLINICALLY PROVEN RELIEF
`IN 60 MINUTES
`
`Stop use and ask a doc or f
`䡲 you have trouble ur nat ng or emptying your
`
` b adder
`䡲 an al ergic react on to this product occurs Seek
`
` medical he p r ght away
`
`chi d en under
`6 years of age
`
`䡲 do not use
`
`consumers with
`k dney d sease
`
`䊳
`
`䡲 do not use
`
`LOT
`
`EXP
`
`UPC
`FPO
`
`Reference ID 4048999
`
`The t ade dress of this Xyzal® package
` is subject to trademark protec ion
`
`Dist By Chattem Inc a Sanofi Company
`Cha tanooga TN 37409 0219
`
`©2017 Origin Sw tzerland
`
`24
`
`HOUR
`RELIEF OF
`
`䊳
`
`XXXXXXX XX
`
`Drug Facts (cont nued)
`Other information
`䡲 s ore be ween 20° and
` 25°C (68° and 77°F)
`䡲 safety sealed: do not use
` if carton was opened or f
` pr n ed foil inner seal on
` bott e is torn or missing
`Inactive ingredients
`co loidal anhydrous sil ca
`hypromel ose lactose
`monohydrate magnesium
`stearate microcrystall ne
`ce lulose po yethylene
`g ycol 400 itan um dioxide
`Questions or
`comments?
`ca l 1 800 633 1610
`
`Read direct ons and warn ngs
`be ore use Keep his car on
`t has important informat on
`
`BONUS! 10 TABLETS FREE
`
`NDC 41167 3510 5
`
`ORIGINAL
`ORIGINAL
`PRESCRIPTION STRENGTH
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
` 5 mg / antihistamine
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`
`Clinically Proven 24 Hour Relief of
`Indoor and Outdoor Allergies
`
`45
`
`3535
`
`TABLETSTABLETS
`
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Label
`01.06.17
`Xyzal_Allergy_45ct_Label_2016_r4_CLEAN
`
`DATA
`MATRIX
`CODE
`FPO
`XXXXXXX-XX
`Dist. By: Chattem, Inc.,
`a Sanofi Company,
`Chattanooga, TN 37409-0219
`©2017 Origin: Switzerland
`
`24
`
`HOUR
`RELIEF OF
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`NDC 41167 3510 5
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS4545
`
`TABLETS
`
`PEEL HERE
`
`䊳
`
`Active ingredient (in each tablet) Purpose
`Levocetirizine dihydrochloride 5 mg.............................Antihistamine
`Uses temporar ly relieves these symptoms due to hay fever or other
`respiratory allergies: 䡲 runny nose 䡲 sneezing 䡲 itchy, watery eyes
`䡲 itching of the nose or throat Warnings Do not use 䡲 if you have
`kidney disease 䡲 if you have ever had an allergic reaction to this
`product or any of its ingredients or to an antihistamine containing
`cetirizine Ask a doctor before use if you have 䡲 ever had trouble
`urinating or emptying your bladder When using this product
`䡲 drowsiness may occur 䡲 avoid alcoholic drinks 䡲 alcohol,
`
`䊳
`
`sedatives, and tranquilizers may increase drowsiness 䡲 be careful when
`driving a motor vehicle or operating machinery Stop use and ask a
`doctor if 䡲 you have trouble urinating or emptying your bladder 䡲 an
`allergic reaction to this product occurs. Seek medical help right away.
`If pregnant or breast-feeding: 䡲 if breast-feeding: not recommended
`䡲 if pregnant: 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 (1-800-222-1222). Directions adults 65
`years of age and older 䡲 ask a doctor adults and children 12-64
`䊳
`years of age 䡲 take 1 tablet (5 mg) once daily in the evening
`
`NDC 41167 3510 5
`
`©2017 Origin: Swizerland
`Chattanooga, TN 37409-0219
`a Sanofi Company,
`Dist. By: Chattem, Inc.,
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS4545
`
`TABLETS
`
`䡲 do not take more than 1 tablet (5 mg) in 24 hours 䡲 ½ tablet (2.5 mg) once
`daily in the evening may be appropriate for less severe symptoms children
`6-11 years of age 䡲 take ½ tablet (2.5 mg) once daily in the evening 䡲 do
`not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of
`age 䡲 do not use consumers with kidney disease 䡲 do not use Other
`information 䡲 store between 20º and 25º C (68º and 77º F) 䡲 safety sealed:
`do not use f carton was opened or if printed foil inner seal on bottle is torn or
`missing Inactive ingredients colloidal anhydrous si ica, hypromellose, lactose
`monohydrate, magnesium stearate, microcrystal ine cellulose, polyethylene
`glycol 400, t tanium dioxide Questions or comments? call 1-800-633-1610
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Carton
`01.06.17
`Xyzal_Allergy_55ct_CTN_2016_r3_CLEAN
`
`Drug Facts (cont nued)
`Other information
`䡲 s ore be ween 20° and
` 25°C (68° and 77°F)
`䡲 safety sealed: do not use
` if carton was opened or f
` pr n ed foil inner seal on
` bott e is torn or missing
`Inactive ingredients
`co loidal anhydrous sil ca
`hypromel ose lactose
`monohydrate magnesium
`stearate microcrystall ne
`ce lulose po yethylene
`g ycol 400 itan um dioxide
`Questions or
`comments?
`ca l 1 800 633 1610
`
`Read direct ons and warn ngs
`be ore use Keep his car on
`t has important informat on
`
`NDC 41167 3510 2
`
`ORIGINAL
`ORIGINAL
`PRESCRIPTION STRENGTH
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
` 5 mg / antihistamine
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`
`Drug Facts
`Active ingredient Purpose
`(in each tablet)
`Levocetir zine d hydrochloride 5 mg
`Ant h s amine
`Uses
`emporari y re ieves these symptoms due to hay
`ever or o her respi atory allergies:
`䡲 runny nose 䡲 tchy watery eyes
`䡲 sneez ng
` 䡲 tching of the nose or throat
`Warnings
`Do not use
`䡲 if you have k dney disease
`䡲 if you have ever had an al ergic react on to this
`
` p oduct or any of ts ing edients or o an
` ant histamine containing cet rizine
`
`Ask a doctor before use if you have
`䡲 ever had trouble urina ing or emptying your
`
` b adder
`
`When using this product
`䡲 d owsiness may occur
`䡲 avoid alcoho ic drinks
`䡲 a cohol sedatives and tranqu l zers may ncrease
` drowsiness
`䡲 be care ul when dr v ng a motor veh c e or
` operat ng machinery
`
`Drug Facts (continued)
`If pregnant or breast feed ng:
`䡲 if breast feed ng: not recommended
`䡲 if pregnant: ask a heal h professional
`
` before use
`Keep out of reach of children.
`In case of overdose get med cal help or
`con act a Po son Con rol Cen er right away
`(1 800 222 1222)
`Directions
`adults 65
`years of age
`and older
`
`䡲 ask a doctor
`
`adults and
`chi d en
`12 64 years
`of age
`
`chi d en 6 11
`years of age
`
`䡲 take 1 tablet (5 mg)
`
` once dai y in the evening
`䡲 do not take more than 1
` tablet (5 mg) in 24 hours
`䡲 ½ tab et (2 5 mg) once
` dai y in the evening may
` be appropriate for ess
` severe symptoms
`
`䡲 take ½ ablet (2 5 mg)
`
` once dai y in the evening
`䡲 do not take more than ½
` tablet (2 5 mg) in 24 hours
`
`CLINICALLY PROVEN RELIEF
`
`FOR 24 HOURS
`
`CLINICALLY PROVEN RELIEF
`IN 60 MINUTES
`
`Stop use and ask a doc or f
`䡲 you have trouble ur nat ng or emptying your
`
` b adder
`䡲 an al ergic react on to this product occurs Seek
`
` medical he p r ght away
`
`chi d en under
`6 years of age
`
`䡲 do not use
`
`consumers with
`k dney d sease
`
`䊳
`
`䡲 do not use
`
`LOT
`
`EXP
`
`UPC
`FPO
`
`Reference ID 4048999
`
`The t ade dress of this Xyzal® package
` is subject to trademark protec ion
`
`Dist By Chattem Inc a Sanofi Company
`Cha tanooga TN 37409 0219
`
`©2017 Origin Sw tzerland
`
`24
`
`HOUR
`RELIEF OF
`
`䊳
`
`0100067 01
`
`TABLETS5555
`
`TABLETS
`
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`Clinically Proven 24 Hour Relief of
`Indoor and Outdoor Allergies
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Label
`01.06.17
`Xyzal_Allergy_55ct_Label_2016_r4_CLEAN
`
`DATA
`MATRIX
`CODE
`FPO
`0100142-01
`Dist. By: Chattem, Inc.,
`a Sanofi Company,
`Chattanooga, TN 37409-0219
`©2017 Origin: Switzerland
`
`24
`
`HOUR
`RELIEF OF
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`NDC 41167 3510 2
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS5555
`
`TABLETS
`
`PEEL HERE
`
`䊳
`
`Active ingredient (in each tablet) Purpose
`Levocetirizine dihydrochloride 5 mg.............................Antihistamine
`Uses temporar ly relieves these symptoms due to hay fever or other
`respiratory allergies: 䡲 runny nose 䡲 sneezing 䡲 itchy, watery eyes
`䡲 itching of the nose or throat Warnings Do not use 䡲 if you have
`kidney disease 䡲 if you have ever had an allergic reaction to this
`product or any of its ingredients or to an antihistamine containing
`cetirizine Ask a doctor before use if you have 䡲 ever had trouble
`urinating or emptying your bladder When using this product
`䡲 drowsiness may occur 䡲 avoid alcoholic drinks 䡲 alcohol,
`
`䊳
`
`sedatives, and tranquilizers may increase drowsiness 䡲 be careful when
`driving a motor vehicle or operating machinery Stop use and ask a
`doctor if 䡲 you have trouble urinating or emptying your bladder 䡲 an
`allergic reaction to this product occurs. Seek medical help right away.
`If pregnant or breast-feeding: 䡲 if breast-feeding: not recommended
`䡲 if pregnant: 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 (1-800-222-1222). Directions adults 65
`years of age and older 䡲 ask a doctor adults and children 12-64
`䊳
`years of age 䡲 take 1 tablet (5 mg) once daily in the evening
`
`NDC 41167 3510 2
`
`©2017 Origin: Swizerland
`Chattanooga, TN 37409-0219
`a Sanofi Company,
`Dist. By: Chattem, Inc.,
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS5555
`
`TABLETS
`
`䡲 do not take more than 1 tablet (5 mg) in 24 hours 䡲 ½ tablet (2.5 mg) once
`daily in the evening may be appropriate for less severe symptoms children
`6-11 years of age 䡲 take ½ tablet (2.5 mg) once daily in the evening 䡲 do
`not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of
`age 䡲 do not use consumers with kidney disease 䡲 do not use Other
`information 䡲 store between 20º and 25º C (68º and 77º F) 䡲 safety sealed:
`do not use f carton was opened or if printed foil inner seal on bottle is torn or
`missing Inactive ingredients colloidal anhydrous si ica, hypromellose, lactose
`monohydrate, magnesium stearate, microcrystal ine cellulose, polyethylene
`glycol 400, t tanium dioxide Questions or comments? call 1-800-633-1610
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Carton
`01.06.17
`Xyzal_Allergy_80ct_CTN_2016_r3_CLEAN
`
`Drug Facts (cont nued)
`Other information
`䡲 s ore be ween 20° and
` 25°C (68° and 77°F)
`䡲 safety sealed: do not use
` if carton was opened or f
` pr n ed foil inner seal on
` bott e is torn or missing
`Inactive ingredients
`co loidal anhydrous sil ca
`hypromel ose lactose
`monohydrate magnesium
`stearate microcrystall ne
`ce lulose po yethylene
`g ycol 400 itan um dioxide
`Questions or
`comments?
`ca l 1 800 633 1610
`
`Read direct ons and warn ngs
`be ore use Keep his car on
`t has important informat on
`
`NDC 41167 3510 3
`
`ORIGINAL
`ORIGINAL
`PRESCRIPTION STRENGTH
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
` 5 mg / antihistamine
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`
`Drug Facts
`Active ingredient Purpose
`(in each tablet)
`Levocetir zine d hydrochloride 5 mg
`Ant h s amine
`Uses
`emporari y re ieves these symptoms due to hay
`ever or o her respi atory allergies:
`䡲 runny nose 䡲 tchy watery eyes
`䡲 sneez ng
` 䡲 tching of the nose or throat
`Warnings
`Do not use
`䡲 if you have k dney disease
`䡲 if you have ever had an al ergic react on to this
`
` p oduct or any of ts ing edients or o an
` ant histamine containing cet rizine
`
`Ask a doctor before use if you have
`䡲 ever had trouble urina ing or emptying your
`
` b adder
`
`When using this product
`䡲 d owsiness may occur
`䡲 avoid alcoho ic drinks
`䡲 a cohol sedatives and tranqu l zers may ncrease
` drowsiness
`䡲 be care ul when dr v ng a motor veh c e or
` operat ng machinery
`
`Drug Facts (continued)
`If pregnant or breast feed ng:
`䡲 if breast feed ng: not recommended
`䡲 if pregnant: ask a heal h professional
`
` before use
`Keep out of reach of children.
`In case of overdose get med cal help or
`con act a Po son Con rol Cen er right away
`(1 800 222 1222)
`Directions
`adults 65
`years of age
`and older
`
`䡲 ask a doctor
`
`adults and
`chi d en
`12 64 years
`of age
`
`chi d en 6 11
`years of age
`
`䡲 take 1 tablet (5 mg)
`
` once dai y in the evening
`䡲 do not take more than 1
` tablet (5 mg) in 24 hours
`䡲 ½ tab et (2 5 mg) once
` dai y in the evening may
` be appropriate for ess
` severe symptoms
`
`䡲 take ½ ablet (2 5 mg)
`
` once dai y in the evening
`䡲 do not take more than ½
` tablet (2 5 mg) in 24 hours
`
`CLINICALLY PROVEN RELIEF
`
`FOR 24 HOURS
`
`CLINICALLY PROVEN RELIEF
`IN 60 MINUTES
`
`Stop use and ask a doc or f
`䡲 you have trouble ur nat ng or emptying your
`
` b adder
`䡲 an al ergic react on to this product occurs Seek
`
` medical he p r ght away
`
`chi d en under
`6 years of age
`
`䡲 do not use
`
`consumers with
`k dney d sease
`
`䊳
`
`䡲 do not use
`
`LOT
`
`EXP
`
`UPC
`FPO
`
`Reference ID 4048999
`
`The t ade dress of this Xyzal® package
` is subject to trademark protec ion
`
`Dist By Chattem Inc a Sanofi Company
`Cha tanooga TN 37409 0219
`
`©2017 Origin Sw tzerland
`
`24
`
`HOUR
`RELIEF OF
`
`䊳
`
`0100068 01
`
`TABLETS8080
`
`TABLETS
`
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`Clinically Proven 24 Hour Relief of
`Indoor and Outdoor Allergies
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Label
`01.06.17
`Xyzal_Allergy_80ct_Label_2016_r4_CLEAN
`
`DATA
`MATRIX
`CODE
`FPO
`0100143-01
`Dist. By: Chattem, Inc.,
`a Sanofi Company,
`Chattanooga, TN 37409-0219
`©2017 Origin: Switzerland
`
`24
`
`HOUR
`RELIEF OF
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`NDC 41167 3510 3
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS8080
`
`TABLETS
`
`PEEL HERE
`
`䊳
`
`Active ingredient (in each tablet) Purpose
`Levocetirizine dihydrochloride 5 mg.............................Antihistamine
`Uses temporar ly relieves these symptoms due to hay fever or other
`respiratory allergies: 䡲 runny nose 䡲 sneezing 䡲 itchy, watery eyes
`䡲 itching of the nose or throat Warnings Do not use 䡲 if you have
`kidney disease 䡲 if you have ever had an allergic reaction to this
`product or any of its ingredients or to an antihistamine containing
`cetirizine Ask a doctor before use if you have 䡲 ever had trouble
`urinating or emptying your bladder When using this product
`䡲 drowsiness may occur 䡲 avoid alcoholic drinks 䡲 alcohol,
`
`䊳
`
`sedatives, and tranquilizers may increase drowsiness 䡲 be careful when
`driving a motor vehicle or operating machinery Stop use and ask a
`doctor if 䡲 you have trouble urinating or emptying your bladder 䡲 an
`allergic reaction to this product occurs. Seek medical help right away.
`If pregnant or breast-feeding: 䡲 if breast-feeding: not recommended
`䡲 if pregnant: 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 (1-800-222-1222). Directions adults 65
`years of age and older 䡲 ask a doctor adults and children 12-64
`䊳
`years of age 䡲 take 1 tablet (5 mg) once daily in the evening
`
`NDC 41167 3510 3
`
`©2017 Origin: Swizerland
`Chattanooga, TN 37409-0219
`a Sanofi Company,
`Dist. By: Chattem, Inc.,
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`®
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
`5 mg / antihistamine
`
`TABLETS8080
`
`TABLETS
`
`䡲 do not take more than 1 tablet (5 mg) in 24 hours 䡲 ½ tablet (2.5 mg) once
`daily in the evening may be appropriate for less severe symptoms children
`6-11 years of age 䡲 take ½ tablet (2.5 mg) once daily in the evening 䡲 do
`not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of
`age 䡲 do not use consumers with kidney disease 䡲 do not use Other
`information 䡲 store between 20º and 25º C (68º and 77º F) 䡲 safety sealed:
`do not use f carton was opened or if printed foil inner seal on bottle is torn or
`missing Inactive ingredients colloidal anhydrous si ica, hypromellose, lactose
`monohydrate, magnesium stearate, microcrystal ine cellulose, polyethylene
`glycol 400, t tanium dioxide Questions or comments? call 1-800-633-1610
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Club Card
`01.06.17
`Xyzal_Allergy_110ct_ClubCard_2016_r3_CLEAN
`
`NDC 41167-3510-4
`
`ORIGINAL
`PRESCRIPTION STRENGTH
`
`®
`
`ALLERGY 24HR
`levocetirizine dihydrochloride tablet
` 5 mg / antihistamine
`
`24
`
`HOUR
`RELIEF OF
`
`SNEEZING
`RUNNY NOSE
`ITCHY NOSE OR THROAT
`ITCHY, WATERY EYES
`
`110110TABLETS
`
`TABLETS
`
`®
`
`ALLERGY 24HR
`
`CLINICALLY PROVEN RELIEF
`IN 60 MINUTES
`
`CLINICALLY PROVEN RELIEF
`FOR 24 HOURS
`
`Drug Facts
`Active ingredient (in each tablet) Purpose
`Levocetirizine dihydrochloride 5 mg.......................... Antihistamine
`
`Uses
`temporarily relieves these symptoms due to hay fever or other
`respiratory allergies:
`䡲 runny nose 䡲 itchy, watery eyes
`䡲 sneezing
` 䡲 itching of the nose or throat
`
`Warnings
`Do not use
`䡲 if you have kidney disease
`䡲 if you have ever had an allergic reaction to this product or
` any of its ingredients or to an antihistamine containing
` cetirizine
`
`Drug Facts (continued)
`Directions
`adults 65 years
`of age and older
`
`䡲 ask a doctor
`
`adults and
`children 12-64
`years of age
`
`children 6-11
`years of age
`
`䡲 take 1 tablet (5 mg) once daily in the evening
`䡲 do not take more than 1 tablet (5 mg)
` in 24 hours
`䡲 ½ tablet (2.5 mg) once daily in the evening
` may be appropriate for less severe symptoms
`
`䡲 take ½ tablet (2.5 mg) once daily in
` the evening
`䡲 do not take more than ½ tablet (2.5 mg)
` in 24 hours
`
`Ask a doctor before use if you have
`䡲 ever had trouble urinating or emptying your bladder
`
`children under
`6 years of age
`
`䡲 do not use
`
`When using this product
`䡲 drowsiness may occur
`䡲 avoid alcoholic drinks
`䡲 alcohol, sedatives, and tranquilizers may increase drowsiness
`䡲 be careful when driving a motor vehicle or operating
`
` machinery
`
`Stop use and ask a doctor if
`䡲 you have trouble urinating or emptying your bladder
`䡲 an allergic reaction to this product occurs. Seek medical help
` right away.
`If pregnant or breast-feeding:
`䡲 if breast-feeding: not recommended
`䡲 if pregnant: 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 (1-800-222-1222).
`
`䊳
`
`䡲 do not use
`
`consumers with
`kidney disease
`Other information
`䡲 store between 20° and 25°C (68° and 77°F)
`䡲 safety sealed: do not use if sealed package was torn or opened,
` or if printed foil inner seal on bottle is torn or missing
`Inactive ingredients
`colloidal anhydrous silica, hypromellose, lactose monohydrate,
`magnesium stearate, microcrystalline cellulose, polyethylene glycol
`400, titanium dioxide
`Questions or comments?
`call 1-800-633-1610
`
`Read directions and warnings before use. Keep this carton.
`It has important information.
`
`UPC
`FPO
`
`The trade dress of this Xyza ® package is subject to trademark protection
`Dist By Chattem, Inc , a Sanofi Company, Chattanooga, TN 37409 0219
`©2017 Origin Switzerland
`
`0051552-01
`
`0051550-01
`
`DATA
`MATRIX
`FPO
`
`Reference ID: 4048999
`
`

`

`Xyzal Allergy 24 Hour Tablet Bottle Induction Seal
`1.22.16
`Xyzal_Allergy Tablet_Bottle Safety Seal_2016
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`5 point Helvetica
`Neue Bold Cond Italic
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
`SEALED for YOUR
`PROTECTION
`
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`
`SEALED for YOUR
`PROTECTION
`
`SEAL