Purposes
`
`Drug Facts
`Active ingredient (in each capsule)
`Naproxen sodium 220 mg
`(naproxen 200 mg) (NSA D)*...................Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses
`● temporarily relieves minor aches and pains due to:
`● backache
`● muscular aches
`● minor pain of arthritis
`● menstrual cramps
`● headache
`● toothache
`● the common cold
`● temporarily reduces fever
`Warnings
`Allergy alert: Naproxen sodium may cause a severe allergic
`reaction, especially in people allergic to aspirin. Symptoms
`may include:
`● hives ● facial swelling ● asthma (wheezing)
`● shock ● skin reddening ● rash ● blisters
`If an allergic reaction occurs, stop use and seek medical help right
`away.
`Stomach bleeding warning: This product contains an NSA D, which
`
`may cause severe stomach bleeding. The chance is higher if you:
`● are age 60 or older
`● have had stomach ulcers or bleeding problems
`● take a blood thinning (anticoagulant) or steroid drug
`● take other drugs containing prescription or nonprescription
`NSAIDs (aspirin, ibuprofen, naproxen, or others)
`● have 3 or more alcoholic drinks every day while using this product
`
`● take more or for a longer time than directed
`Heart attack and stroke warning: NSAIDs, except aspirin, increase
`the risk of heart attack, heart failure, and stroke. These can be fatal.
`The risk is higher if you use more than directed or for longer than
`directed.
`Do not use
`● if you have ever had an allergic reaction to any other pain
` reliever/fever reducer
`● right before or after heart surgery
`
`
`naproxen sodium
`capsules, 220 mg
`(NSAID)
`pain reliever/fever reducer
`
`***Compare to the active ingredient in ALEVE® BACK & MUSCLE PAIN
`
`naproxen sodium
`capsules, 220 mg (NSAID)
`pain reliever/fever reducer
`
`NDC 69452-269-16
`
`Actual Size
`
`12 hour back & muscle pain relief
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` cap is torn or missing.
`
`Do not use if printed safety seal under
`
`50 capsules**
`**liquid-filled capsule
`
`for temporary relief of minor back
`
`and muscle aches and pains
`
`Drug Facts (continued)
`Ask a doctor before use if
`● the stomach bleeding warning applies to you
`● you have a history of stomach problems, such as heartburn
`● you have high blood pressure, heart disease, liver cirrhosis,
`kidney disease, asthma, or had a stroke
`● you are taking a diuretic
`● you have problems or serious side effects from taking pain
`relievers or fever reducers
`Ask a doctor or pharmacist before use if you are
`● under a doctor's care for any serious condition
`● taking aspirin for heart attack or stroke, because naproxen may
` decrease this benefit of aspirin
`● taking any other drug
`When using this product
`● take with food or milk if stomach upset occurs
`Stop use and ask a doctor if
`● you experience any of the following signs of stomach
`bleeding:
`● feel faint ● vomit blood ● have bloody or black stools
`● have stomach pain that does not get better
`● you have symptoms of heart problems or stroke:
`
`● chest pain ● trouble breathing
`● weakness in one part or side of body ● slurred speech
`● leg swelling
`● pain gets worse or lasts more than 10 days
`● fever gets worse or lasts more than 3 days
`● you have difficulty swallowing
`
`
`● it feels like the capsule is stuck in your throat
`● redness or swelling is present in the painful area
`● any new symptoms appear
`If pregnant or breast-feeding, ask a health professional before use.
`
`
`It is especially important not to use naproxen sodium during the last
`3 months of pregnancy unless definitely directed to do so by a
`
`doctor because it may cause problems in the unborn child or
`
`
`
`complications during delivery.
`
`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
`● do not take more than directed
`
`● the smallest effective dose should be used
`● drink a full glass of water with each dose
`● if taken with food, this product may take longer to work
`● take 1 capsule every 8 hours to 12 hours while
`Adults and
`symptoms last
`children
`● for the first dose you may take 2 capsules within
`12 years
` the first hour
`and older
`● do not exceed 2 capsules in any 8-hour to 12-hour
`period
`● do not exceed 3 capsules in a 24-hour period
`● ask a doctor
`
`Children under
`12 years
`Other information
`● each capsule contains: sodium 20 mg
`● store at 20° to 25°C (68° to 77°F). Avoid high humidity and
`excessive heat above 40°C (104°F).
`● read all directions and warnings before use. Keep carton.
`Inactive ingredients
`FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical
`ink, polyethylene FD&C blue #1, gelatin, glycerin, lactic acid, mannitol,
`pharmaceutical ink, polyethylene glycol, povidone, propylene glycol,
`purified water, sorbitan, sorbitol
`Questions or comments?
`call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
`
`Manufactured for:
`BIONPHARMA
`600 Alexander Road,
`Princeton, NJ 08540
`
`L0000000
`R1019
`
`***This product is not manufactured or distributed by the
`owners of ALEVE® Back & Muscle pain.
`
`3
`
`6 9 4 5 2
`
`2 6 9 1 6
`
`9
`
`Lot No.:
`Exp. Date:
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique Georgia
`
`Drug Facts:
`8pt
`Header:
` 7pt
` 6pt
`Subheader:
` 6pt
`Body Text:
`Drug Facts (continued): 7pt
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
` 7pt
`5pt
` 0.6pt
` 0.2pt
`
`Horizontal Scale: 100%
`
`Average Kerning: 0%
`
`Reference ID: 4511736
`
`

`

`Purposes
`
`Drug Facts
`Active ingredient (in each capsule)
`Naproxen sodium 220 mg
`(naproxen 200 mg) (NSA D)*...................Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses
`● temporarily relieves minor aches and pains due to:
`● backache
`● muscular aches
`● minor pain of arthritis
`● menstrual cramps
`● headache
`● toothache
`● the common cold
`● temporarily reduces fever
`Warnings
`Allergy alert: Naproxen sodium may cause a severe allergic
`reaction, especially in people allergic to aspirin. Symptoms
`may include:
`● hives ● facial swelling ● asthma (wheezing)
`● shock ● skin reddening ● rash ● blisters
`If an allergic reaction occurs, stop use and seek medical help right
`away.
`Stomach bleeding warning: This product contains an NSA D, which
`
`may cause severe stomach bleeding. The chance is higher if you:
`● are age 60 or older
`● have had stomach ulcers or bleeding problems
`● take a blood thinning (anticoagulant) or steroid drug
`● take other drugs containing prescription or nonprescription
`NSAIDs (aspirin, ibuprofen, naproxen, or others)
`● have 3 or more alcoholic drinks every day while using this product
`
`● take more or for a longer time than directed
`Heart attack and stroke warning: NSAIDs, except aspirin, increase
`the risk of heart attack, heart failure, and stroke. These can be fatal.
`The risk is higher if you use more than directed or for longer than
`directed.
`Do not use
`● if you have ever had an allergic reaction to any other pain
` reliever/fever reducer
`● right before or after heart surgery
`
`
`naproxen sodium
`capsules, 220 mg
`(NSAID)
`pain reliever/fever reducer
`
`naproxen sodium
`capsules, 220 mg (NSAID)
`pain reliever/fever reducer
`
`NDC 69452-269-16
`
`Actual Size
`
`12 hour back & muscle pain relief
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` cap is torn or missing.
`
`Do not use if printed safety seal under
`
`50 capsules**
`**liquid-filled capsule
`
`for temporary relief of minor back
`
`and muscle aches and pains
`
`Drug Facts (continued)
`Ask a doctor before use if
`● the stomach bleeding warning applies to you
`● you have a history of stomach problems, such as heartburn
`● you have high blood pressure, heart disease, liver cirrhosis,
`kidney disease, asthma, or had a stroke
`● you are taking a diuretic
`● you have problems or serious side effects from taking pain
`relievers or fever reducers
`Ask a doctor or pharmacist before use if you are
`● under a doctor's care for any serious condition
`● taking aspirin for heart attack or stroke, because naproxen may
`decrease this benefit of aspirin
`● taking any other drug
`When using this product
`● take with food or milk if stomach upset occurs
`Stop use and ask a doctor if
`● you experience any of the following signs of stomach
` bleeding:
`● feel faint ● vomit blood ● have bloody or black stools
`● have stomach pain that does not get better
`● you have symptoms of heart problems or stroke:
`
`● chest pain ● trouble breathing
`● weakness in one part or side of body ● slurred speech
`● leg swelling
`● pain gets worse or lasts more than 10 days
`● fever gets worse or lasts more than 3 days
`● you have difficulty swallowing
`
`
`● it feels like the capsule is stuck in your throat
`● redness or swelling is present in the painful area
`● any new symptoms appear
`If pregnant or breast-feeding, ask a health professional before use.
`
`
`It is especially important not to use naproxen sodium during the last
`3 months of pregnancy unless definitely directed to do so by a
`
`doctor because it may cause problems in the unborn child or
`
`
`
`complications during delivery.
`
`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
`● do not take more than directed
`
`● the smallest effective dose should be used
`● drink a full glass of water with each dose
`● if taken with food, this product may take longer to work
`● take 1 capsule every 8 hours to 12 hours while
`Adults and
`symptoms last
`children
`● for the first dose you may take 2 capsules within
`12 years
` the first hour
`and older
`● do not exceed 2 capsules in any 8-hour to 12-hour
`period
`● do not exceed 3 capsules in a 24-hour period
`● ask a doctor
`
`Children under
`12 years
`Other information
`● each capsule contains: sodium 20 mg
`● store at 20° to 25°C (68° to 77°F). Avoid high humidity and
` excessive heat above 40°C (104°F).
`● read all directions and warnings before use. Keep carton.
`Inactive ingredients
`FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical
`ink, polyethylene FD&C blue #1, gelatin, glycerin, lactic acid, mannitol,
`pharmaceutical ink, polyethylene glycol, povidone, propylene glycol,
`purified water, sorbitan, sorbitol
`Questions or comments?
`call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
`
`Manufactured for:
`BIONPHARMA
`600 Alexander Road,
`Princeton, NJ 08540
`
`L0000000
`R1019
`
`3
`
`6 9 4 5 2
`
`2 6 9 1 6
`
`9
`
`Lot No.:
`Exp. Date:
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique Georgia
`
`Drug Facts:
`8pt
`Header:
` 7pt
` 6pt
`Subheader:
` 6pt
`Body Text:
`Drug Facts (continued): 7pt
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
` 7pt
`5pt
` 0.6pt
` 0.2pt
`
`Horizontal Scale: 100%
`
`Average Kerning: 0%
`
`Reference ID: 4511736
`
`

`

`.125” corner radius
`
`Non Varnish Area
`
`Manufactured for:
`call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
`Questions or comments?
`not exceed 3 capsules in a 24-hour period. Children under 12 years: ask a doctor.
`symptoms last. For the first dose you may take 2 capsules within the first hour. Do
`12 years and older: take 1 capsule with water every 8 hours to 12 hours while
`contact a Poison Control Center right away. Directions Adults and children
`use. Keep out of reach of children. In case of overdose, get medical help or
`fever gets worse. If pregnant or breast-feeding, ask a health professional before
`weakness in one part or side of body, slurred speech, leg swelling), or if pain or
`better), have symptoms of heart problems or stroke (chest pain, trouble breathing,
`vomit blood, have bloody or black stools, have stomach pain that does not get
`doctor if you experience any of the following signs of stomach bleeding (feel faint,
`may decrease this benefit of aspirin ● taking any other drug. Stop use and ask a
`serious condition ● taking aspirin for heart attack or stroke, because naproxen
`Ask a doctor or pharmacist before use if you are ● under a doctor's care for any
`use if you have ever had an alergic reaction to any other pain reliever/fever reducer.
`The risk is higher if you use more than directed or for longer than directed. Do not
`aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal.
` longer time than directed. Heart attack and stroke warning: NSAIDs, except
`more alcoholic drinks every day while using this product ● take more or for a
`nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or
`(anticoagulant) or steroid drug ● take other drugs containing prescription or
`● have had stomach ulcers or bleeding problems ● take a blood thinning
`cause severe stomach bleeding. The chance is higher if you: ● are age 60 or older
`This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may
`occurs, stop use and seek medical help right away. Stomach bleeding warning:
`asthma (wheezing),shock, skin reddening, rash, or blisters. If an allergic reaction
`especialy in people allergic to aspirin. Symptoms may include: hives, facial swelling,
`Warnings Allergy alert: Naproxen sodium may cause a severe alergic reaction,
`
`AND PRODUCT INFORMATION
`
`R1019
`L0000000
`
`Lot/EXP
`
` Princeton, NJ 08540
` 600 Alexander Road,
`IONPHARMA
`
`B
`
`KEEP OUTER CARTON FOR COMPLETE WARNINGS
`Do not use if printed safety seal under cap is torn or missing.
`
`NDC 69452-269-16
`naproxen sodium
`capsules, 220 mg
`(NSAID)
`pain reliever/fever reducer
`
`12 hour back &
`muscle pain relief
`for temporary relief of minor back
`and muscle aches and pains
`50 capsules**
`**liquid-filled capsule
`
`1.75”
`
`4.50”
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique Georgia
`
`Drug Facts:
`NA
`Header:
` 5pt
` 4.5pt
`Subheader:
` 4.5pt
`Body Text:
`Drug Facts (continued): NA
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
` 5pt
`3.5pt
` NA
` NA
`
`Horizontal Scale: 100%
`
`Average Kerning: 0%
`
`Reference ID: 4511736
`
`

`

`.125” corner radius
`
`Non Varnish Area
`
`R1019
`
`6
`
`L0000000
`26920
`
`69452
`
`3
`
`Lot/EXP
` Princeton, NJ 08540
` 600 Alexander Road,
`
`BIONPHARMA
`
`Manufactured for:
`
`***This product is not manufactured or distributed by the owners of ALEVE® Back & Muscle pain.
`
`Front
`
`Drug Facts
`Active ingredient (in each capsule) Purposes
`Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*...Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses ● temporarily relieves minor aches and pains due to:
` ● backache ● muscular aches ● minor pain of arthritis
`
` ● menstrual cramps ● headache ● toothache ● the common cold
`● temporarily reduces fever
`
`Do not use ● if you have ever had an allergic reaction to any other pain
`reliever/ fever reducer ● right before or after heart surgery
`
`
`
`***Compare to the active ingredient in
`ALEVE® BACK & MUSCLE PAIN
`NDC 69452-269-20
`
`naproxen sodium
`capsules, 220 mg (NSAID)
`pain reliever/fever reducer
`
`12 hour back & muscle pain relief
`
`
`
`
`
`Actual Size
`
`100 capsules**
`**liquid-filled capsule
`
`for temporary relief of
`minor back and muscle
`aches and pains
`Do not use if printed safety seal
` under cap is torn or missing.
`
` call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
`Questions or comments?
`water, sorbitan, sorbitol
`pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified
`Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol,
`heat above 40°C (104°F). ● read all directions and warnings before use.
`● store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive
`Other information ● each capsule contains: sodium 20 mg
`12 years
`Children under
`older
`12years and
`children
`Adults and
`● if taken with food, this product may take longer to work
`dose should be used ● drink a full glass of water with each dose
`Directions ● do not take more than directed ● the smallest effective
`contact a Poison Control Center right away.
`Keep out of reach of children. In case of overdose, get medical help or
`cause problems in the unborn child or complications during delivery.
`pregnancy unless definitely directed to do so by a doctor because it may
`especially important not to use naproxen sodium during the last 3 months of
`If pregnant or breast-feeding, ask a health professional before use. It is
`● any new symptoms appear
`is stuck in your throat ● redness or swelling is present in the painful area
`more than 3 days ● you have difficulty swallowing ● it feels like the capsule
`● pain gets worse or lasts more than 10 days ● fever gets worse or lasts
` ● slurred speech ● leg swelling
` ● chest pain ● trouble breathing ● weakness in one part or side of body
`● you have symptoms of heart problems or stroke:
` ● have bloody or black stools ● have stomach pain that does not get better
` ● feel faint ● vomit blood
`● you experience any of the following signs of stomach bleeding:
`Stop use and ask a doctor if
`When using this product ● take with food or milk if stomach upset occurs
`naproxen may decrease this benefit of aspirin ● taking any other drug
`any serious condition ● taking aspirin for heart attack or stroke, because
`Ask a doctor or pharmacist before use if you are ● under a doctor's care for
`side effects from taking pain relievers or fever reducers
`had a stroke ● you are taking a diuretic ● you have problems or serious
`high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or
`● you have a history of stomach problems, such as heartburn ● you have
`Ask a doctor before use if ● the stomach bleeding warning applies to you
`Drug Facts(continued)
`
`
`
`
`
`
`● ask a doctor
`● do not exceed 3 capsules in a 24-hour period
`● do not exceed 2 capsules in any 8-hour to 12-hour period
`● for the first dose you may take 2 capsules within the first hour
`● take 1 capsule every 8 hours to 12 hours while symptoms last
`
`
`
`
`
`
`6.00”
`
`Back
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6.00”
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique Georgia
`
`Drug Facts:
`8pt
`Header:
` 7pt
` 6pt
`Subheader:
` 6pt
`Body Text:
`Drug Facts (continued): 7pt
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
` 5pt
`5pt
` 0.6pt
` 0.2pt
`
`Horizontal Scale: 100%
`
`Average Kerning: 0%
`
`2.375”
`
`
`
`2.375”2.375”
`
`Reference ID: 4511736
`
`(b) (4)
`
`

`

`.125” corner radius
`
`Non Varnish Area
`
`R1019
`
`6
`
`L0000000
`26920
`
`69452
`
`3
`
`Lot/EXP
` Princeton, NJ 08540
` 600 Alexander Road,
`
`BIONPHARMA
`
`Manufactured for:
`
`NDC 69452-269-20
`
`naproxen sodium
`capsules, 220 mg (NSAID)
`pain reliever/fever reducer
`
`12 hour back & muscle pain relief
`
`
`
`
`
`Actual Size
`
`100 capsules**
`**liquid-filled capsule
`
`for temporary relief of
`minor back and muscle
`aches and pains
`Do not use if printed safety seal
` under cap is torn or missing.
`
`Front
`
`Drug Facts
`Active ingredient (in each capsule) Purposes
`Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*...Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses ● temporarily relieves minor aches and pains due to:
` ● backache ● muscular aches ● minor pain of arthritis
`
` ● menstrual cramps ● headache ● toothache ● the common cold
`● temporarily reduces fever
`
`Do not use ● if you have ever had an allergic reaction to any other pain
`reliever/ fever reducer ● right before or after heart surgery
`
`
`
` call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
`Questions or comments?
`water, sorbitan, sorbitol
`pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified
`Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid, mannitol,
`heat above 40°C (104°F). ● read all directions and warnings before use.
`● store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive
`Other information ● each capsule contains: sodium 20 mg
`12 years
`Children under
`older
`12years and
`children
`Adults and
`● if taken with food, this product may take longer to work
`dose should be used ● drink a full glass of water with each dose
`Directions ● do not take more than directed ● the smallest effective
`contact a Poison Control Center right away.
`Keep out of reach of children. In case of overdose, get medical help or
`cause problems in the unborn child or complications during delivery.
`pregnancy unless definitely directed to do so by a doctor because it may
`especially important not to use naproxen sodium during the last 3 months of
`If pregnant or breast-feeding, ask a health professional before use. It is
`● any new symptoms appear
`is stuck in your throat ● redness or swelling is present in the painful area
`more than 3 days ● you have difficulty swallowing ● it feels like the capsule
`● pain gets worse or lasts more than 10 days ● fever gets worse or lasts
` ● slurred speech ● leg swelling
` ● chest pain ● trouble breathing ● weakness in one part or side of body
`● you have symptoms of heart problems or stroke:
` ● have bloody or black stools ● have stomach pain that does not get better
` ● feel faint ● vomit blood
`● you experience any of the following signs of stomach bleeding:
`Stop use and ask a doctor if
`When using this product ● take with food or milk if stomach upset occurs
`naproxen may decrease this benefit of aspirin ● taking any other drug
`any serious condition ● taking aspirin for heart attack or stroke, because
`Ask a doctor or pharmacist before use if you are ● under a doctor's care for
`side effects from taking pain relievers or fever reducers
`had a stroke ● you are taking a diuretic ● you have problems or serious
`high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or
`● you have a history of stomach problems, such as heartburn ● you have
`Ask a doctor before use if ● the stomach bleeding warning applies to you
`Drug Facts(continued)
`
`
`
`
`
`
`● ask a doctor
`● do not exceed 3 capsules in a 24-hour period
`● do not exceed 2 capsules in any 8-hour to 12-hour period
`● for the first dose you may take 2 capsules within the first hour
`● take 1 capsule every 8 hours to 12 hours while symptoms last
`
`
`
`
`
`
`6.00”
`
`Back
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6.00”
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique Georgia
`
`Drug Facts:
`8pt
`Header:
` 7pt
` 6pt
`Subheader:
` 6pt
`Body Text:
`Drug Facts (continued): 7pt
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
` 5pt
`5pt
` 0.6pt
` 0.2pt
`
`Horizontal Scale: 100%
`
`Average Kerning: 0%
`
`2.375”
`
`
`
`2.375”2.375”
`
`Reference ID: 4511736
`
`(b) (4)
`
`

`

`naproxen sodium
`capsules, 220 mg
`(NSAID)
`pain reliever/fever reducer
`
`Do not use if printed safety seal under
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` cap is torn or missing.
`
`Drug Facts
`Active ingredient (in each capsule) Purposes
`Naproxen sodium 220 mg
`(naproxen 200 mg) (NSA D)*.........Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses
`● temporarily relieves minor aches and pains due to:
` ● menstrual cramps ● muscular aches
` ● headache ● backache ● minor pain of arthritis
` ● toothache ● the common cold
`● temporarily reduces fever
`Warnings
`Allergy alert:
` Naproxen sodium may cause a severe allergic
`reaction, especially in people allergic to aspirin. Symptoms
`may include: ● hives ● facial swelling ● asthma (wheezing)
`● shock ● skin reddening ● rash ● blisters
`f an allergic reaction occurs, stop use and seek medical help
`right away.
`Stomach bleeding warning: This product contains an
`NSA D, which may cause severe stomach bleeding. The
`chance is higher if you: ● are age 60 or older ● have had
`stomach ulcers or bleeding problems ● take a blood
`thinning (anticoagulant) or steroid drug ● take other drugs
`containing prescription or nonprescription NSAIDs (aspirin,
`ibuprofen, naproxen, or others) ● have 3 or more alcoholic
`drinks every day while using this product ● take more or
`for a longer time than directed
`Heart attack and stroke warning: NSAIDs, except aspirin,
`increase the risk of heart attack, heart failure, and stroke.
`These can be fatal. The risk is higher if you use more than
`directed or for longer than directed.
`
`***compare to the active ingredient in MenstridolTM
`
`naproxen sodium
`capsules, 220 mg (NSAID)
`pain reliever/fever reducer
`
`NDC 69452-270-11
`
`Actual Size
`
`20 capsules**
`**liquid-filled capsule
`
`12 hour menstrual pain relief
`
`temporarily relieves minor cramps,
`
`backache, and headache
`
`Drug Facts (continued)
`Do not use
`● if you have ever had an allergic reaction to any other pain
`reliever/fever reducer ● right before or after heart surgery
`Ask a doctor before use if
`● the stomach bleeding warning applies to you
`● you have a history of stomach problems, such as heartburn
`● you have high blood pressure, heart disease, liver cirrhosis,
` kidney disease, asthma, or had a stroke
`● you are taking a diuretic
`● you have problems or serious side effects from taking pain
` relievers or fever reducers
`Ask a doctor or pharmacist before use if you are
`● under a doctor's care for any serious condition
`● taking aspirin for heart attack or stroke, because naproxen
` may decrease this benefit of aspirin
`● taking any other drug
`When using this product
`● take with food or milk if stomach upset occurs
`Stop use and ask a doctor if
`● you experience any of the following signs of stomach
` bleeding: ● feel faint ● vomit blood
` ● have bloody or black stools
` ● have stomach pain that does not get better
`● you have symptoms of heart problems or stroke:
` ● chest pain ● trouble breathing
` ● weakness in one part or side of body
` ● slurred speech ● leg swelling
`● pain gets worse or lasts more than 10 days
`● fever gets worse or lasts more than 3 days
`● you have difficulty swa lowing
`● it feels like the capsule is stuck in your throat
`● redness or swelling is present in the painful area
`● any new symptoms appear
`
`
`
`Drug Facts (continued)
`If pregnant or breast-feeding, ask a health professional
`before use. It is especially important not to use naproxen
`sodium during the last 3 months of pregnancy unless
`definitely directed to do so by a doctor because it may cause
`problems in the unborn child or complications during delivery.
`Keep out of reach of children. In case of overdose, get
`medical help or contact a Poison Control Center right away.
`Directions
`● do not take more than directed
`● the smallest effective dose should be used
` ● drink a full glass of water with each dose
` ● if taken with food, this product may take longer to work
`under
` ● ask a doctor
`12 years
`adults and
`children
`12 years
`and older
`
`● take 1 capsule every 8 hours to 12 hours wh le
` symptoms last
`● for the first dose you may take 2 capsules
` within the first hour
`● do not exceed 2 capsules in any 8-hour to
` 12-hour period
`● do not exceed 3 capsules in a 24-hour period
`Other information
`● each capsule contains: sodium 20 mg
`● store at 20° to 25°C (68° to 77°F). Avoid high humidity and
` excessive heat above 40°C (104°F).
`● read a l directions and warnings before use. Keep carton.
`Inactive ingredients FD&C blue #1, gelatin, glycerin,
`lactic acid, mannitol, pharmaceutical ink, polyethylene glycol,
`povidone, propylene glycol, purified water, sorbitan, sorbitol
`Questions or comments?
`call toll-free 1-888-235-2466 (MonߚFri 9 AMߚ5 PM EST)
`
`
`
`L0000000
`R1019
`
`***This product is not manufactured or distributed by the owners of MenstridolTM.
`
`Manufactured for:
`BIONPHARMA
`600 Alexander Road, Princeton, NJ 08540
`
`3
`
`6 9 4 5 2
`
`2 7 0 1 1
`
`0
`
`Lot No.:
`Exp. Date:
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique Georgia
`
`Drug Facts:
`8pt
`Header:
` 7pt
` 6pt
`Subheader:
` 6pt
`Body Text:
`Drug Facts (continued): 7pt
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
` 7pt
`5pt
` 0.6pt
` 0.2pt
`
`Horizontal Scale: 100%
`
`Average Kerning: 0%
`
`Reference ID: 4511736
`
`

`

`naproxen sodium
`capsules, 220 mg
`(NSAID)
`pain reliever/fever reducer
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` cap is torn or missing.
`
`Do not use if printed safety seal under
`
`Drug Facts
`Active ingredient (in each capsule) Purposes
`Naproxen sodium 220 mg
`(naproxen 200 mg) (NSA D)*.....................Pain reliever/fever reducer
`*nonsteroidal anti-inflammatory drug
`Uses
`● temporarily relieves minor aches and pains due to:
` ● menstrual cramps ● muscular aches
` ● headache ● backache ● minor pain of arthritis
` ● toothache ● the common cold
`● temporarily reduces fever
`Warnings
`Allergy alert:
` Naproxen sodium may cause a severe allergic
`reaction, especially in people allergic to aspirin. Symptoms
`may include: ● hives ● facial swelling ● asthma
`(wheezing) ● shock ● skin reddening ● rash ● blisters
`If an allergic reaction occurs, stop use and seek medical
`help right away.
`Stomach bleeding warning: This product contains an
`NSAID, which may cause severe stomach bleeding. The
`chance is higher if you: ● are age 60 or older ● have had
`stomach ulcers or bleeding problems ● take a blood
`thinning (anticoagulant) or steroid drug ● take other
`drugs containing prescription or nonprescription NSA Ds
`(aspirin, ibuprofen, naproxen, or others) ● have 3 or
`more alcoholic drinks every day while using this product
`● take more or for a longer time than directed
`Heart attack and stroke warning: NSA Ds, except aspirin,
`increase the risk of heart attack, heart failure, and stroke.
`These can be fatal. The risk is higher if you use more than
`directed or for longer than directed.
`Do not use
`● if you have ever had an allergic reaction to any other
`pain reliever/fever reducer ● right before or after heart
`surgery
`
`***compare to the active ingredient in MenstridolTM
`
`naproxen sodium
`capsules, 220 mg (NSAID)
`pain reliever/fever reducer
`
`NDC 69452-270-15
`
`Actual Size
`
`12 hour menstrual pain relief
`
`40 capsules**
`**liquid-filled capsule
`
`temporarily relieves minor cramps,
`
`backache, and headache
`
`Drug Facts (continued)
`Directions
`● do not take more than directed
`● the smallest effective dose should be used
`● drink a full glass of water with each dose
`● if taken with food, this product may take longer to work
`under
`● ask a doctor
`12 years
`adults and
`children
`12 years
`and older
`
`● take 1 capsule every 8 hours to 12 hours
` while symptoms last
`● for the first dose you may take 2 capsules
` within the first hour
`● do not exceed 2 capsules in any 8-hour to
` 12-hour period
`● do not exceed 3 capsules in a 24-hour
` period
`Other information
`● each capsule contains: sodium 20 mg
`● store at 20° to 25°C (68° to 77°F). Avoid high humidity
` and excessive heat above 40°C (104°˚F).
`● read all directions and warnings before use. Keep carton.
`Inactive ingredients
`FD&C blue #1, gelatin, glycerin, lactic acid, mannitol,
`pharmaceutical ink, polyethylene glycol, povidone,
`propylene glycol, purified water, sorbitan, sorbitol
`Questions or comments?
`call toll-free 1-888 235-2466 (Mon - Fri 9AM - 5PM EST)
`
`Manufactured for:
`BIONPHARMA
`600 Alexander Road,
` Princeton, NJ 08540
`
`L0000000
`
`R1019
`
`Drug Facts (continued)
`Ask a doctor before use if
`● the stomach bleeding warning applies to you ● you
`have a history of stomach problems, such as heartburn
`● you have high blood pressure, heart disease, liver
`cirrhosis, kidney disease, asthma, or had a stroke ● you
`are taking a diuretic ● you have problems or serious side
`effects from taking pain relievers or fever reducers
`Ask a doctor or pharmacist before use if you are
`● under a doctor's care for any serious condition
`● taking aspirin for heart attack or stroke, because
`naproxen may decrease this benefit of aspirin
`● taking any other drug
`When using this product
`● take with food or milk if stomach upset occurs
`Stop use and ask a doctor if
`● you experience any of the following signs of stomach
` bleeding: ● feel faint ● vomi