.125” corner radius
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`R0519
`L0000000
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`Non Varnish Area
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`Do not use if printed safety seal under cap is torn or missing.
`
`2.375”
`
`Be
`Health
`Naproxen Sodium
`Capsules, 220 mg
`(NSAID)
`
`Pain reliever/fever reducer
`
`80 Capsules**
`
`**Liquid-filled capsule
`
`Strength to
`last 12 hours
`
`Distributed by:
`Questions or comments? 1 888-235-2466 (Mon - Fri 9AM -5PM EST)
`24-hour period. Children under 12 years: ask a doctor.
`capsules within the first hour. Do not exceed 3 capsules in a
`hours while symptoms last. For the first dose you may take 2
`children 12 years and older: take 1 capsule with water every 8 to 12
`contact a Poison Control Center right away. Directions Adults and
`of reach of children. In case of overdose, get medical help or
`or breast-feeding, ask a health professional before use. Keep out
`that does not get better), or if pain or fever gets worse. If pregnant
`faint, vomit blood, have bloody or black stools, have stomach pain
`experience any of the following signs of stomach bleeding (feel
`aspirin ● taking any other drug Stop use and ask a doctor if you
`attack or stroke, because naproxen may decrease this benefit of
`a doctor's care for any serious condition ● taking aspirin for heart
`reducer. Ask a doctor or pharmacist before use if you are ● under
`have ever had an allergic reaction to any other pain reliever/fever
`more than directed or for longer than directed. Do not use if you
`failure, and stroke. These can be fatal. The risk is higher if you use
`NSAIDs, except aspirin, increase the risk of heart attack, heart
`for a longer time than directed. Heart attack and stroke warning:
`alcoholic drinks every day while using this product ● take more or
`NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more
`● take other drugs containing prescription or nonprescription
`problems ● take a blood thinning (anticoagulant) or steroid drug
`you: ● are age 60 or older ● have had stomach ulcers or bleeding
`which may cause severe stomach bleeding. The chance is higher if
`product contains a nonsteroidal anti-inflammatory drug (NSAID),
`and seek medical help right away. Stomach bleeding warning: This
`reddening, rash, or blisters. If an allergic reaction occurs, stop use
`may include: hives, facial swelling, asthma (wheezing), shock, skin
`allergic reaction, especially in people allergic to aspirin. Symptoms
`Warnings Allergy alert: Naproxen sodium may cause a severe
`KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
`
`Lot/EXP
`Princeton, NJ 08540
`600 Alexander Road,
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`BIONPHARMA
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`6.00”
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`
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique
`
`Drug Facts:
`
`N/A
`Header:
` 6pt
`Subheader:
`
`6pt
`Body Text:
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`
`6pt
`Drug Facts (continued): N/A
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`Leading:
`Bullets:
`Barlines:
`Hairlines:
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`6.5pt
` 3.5pt
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`N/A
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`N/A
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`Horizontal Scale: 100%
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`Average Kerning: 0%
`
`Reference ID: 4567251
`
`

`

`
`
`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique
`
`Drug Facts:
`
`14pt
`Header:
` 8pt
`Subheader:
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`6pt
`Body Text:
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`6pt
`Drug Facts (continued): N/A
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`Leading:
`Bullets:
`Barlines:
`Hairlines:
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`6.5pt
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`2.431pt
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`.486pt
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`Horizontal Scale: 94%
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`Average Kerning: 0%
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`● headache
`● toothache
`● muscular aches ● backache
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`severe stomach bleeding. The chance is higher if you:
`Stomach bleeding warning: This product contains an NSAID, which may cause
`If an allergic reaction occurs, stop use and seek medical help right away.
`● rash ● blisters
`● hives ● facial swelling ● asthma (wheezing) ● shock ● skin reddening
`people allergic to aspirin. Symptoms may include:
`Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in
`Warnings
`● temporarily reduces fever
`
`● the common cold
`● menstrual cramps
`● minor pain of arthritis
`● temporarily relieves minor aches and pains due to:
`Uses
`*nonsteroidal anti-inflammatory drug
`(naproxen 200 mg) (NSAID)*...........................................Pain reliever/fever reducer
`Naproxen sodium 220 mg
`Purposes
`Active ingredient (in each capsule)
`Drug Facts
`
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`● take other drugs containing prescription or nonprescription NSAIDs (aspirin,
`● take a blood thinning (anticoagulant) or steroid drug
`● have had stomach ulcers or bleeding problems
`● are age 60 or older
`
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`
`
`
`
`
`
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`
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`● take more or for a longer time than directed
`● have 3 or more alcoholic drinks every day while using this product
`
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`ibuprofen, naproxen, or others)
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`● taking aspirin for heart attack or stroke, because naproxen may decrease this
`● under a doctor's care for any serious condition
`Ask a doctor or pharmacist before use if you are
` reducers
`● you have problems or serious side effects from taking pain relievers or fever
`● you are taking a diuretic
` asthma, or had a stroke
`● you have high blood pressure, heart disease, liver cirrhosis, kidney disease,
`● you have a history of stomach problems, such as heartburn
`● stomach bleeding warning applies to you
`Ask a doctor before use if
`● right before or after heart surgery
`● if you have ever had an allergic reaction to any other pain reliever/fever reducer
`Do not use
`use more than directed or for longer than directed.
`heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you
`Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of
`
`● taking any other drug
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`benefit of aspirin
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`Exp. Date:
`Lot No.:
`
`
`
`Distributed by:
`
`***This product is not manufactured or distributed by the owners
`
`of ALEVE® Liquid Gels.
`
`Be
`Health
`Naproxen Sodium
`Capsules, 220 mg
`(NSAID)
`
`Do not use if printed safety seal under cap is
`torn or missing.
`
`Be
`Health
`
`NDC 69452-179-78
`
`†Compare to the active ingredient
`in ALEVE® Liquid Gels
`
`Naproxen Sodium Capsules, 220 mg
`(NSAID)
`
`Pain reliever/fever reducer
`
`Princeton, NJ 08540
`600 Alexander Road,
`
`
`
`
`
`BIONPHARMA
`
`
`
`80 Capsules**
`
`**Liquid-filled capsule
`
`Strength to last 12 hours
`
`last 12 hours
`Strength to
`
`R0519
`
`L0000000
`
`80 Capsules**
`
`**Liquid-filled capsule
`
`Pain reliever/fever reducer
`
`NDC 69452-179-78
`
`(NSAID)
`Capsules, 220 mg
`Naproxen Sodium
`
`in ALEVE® Liquid Gels
`† Compare to the active ingredient
`Health
`Be
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`12 years and older:
`adults and children
`● if taken with food, this product may take longer to work
`● drink a full glass of water with each dose
`● the smallest effective dose should be used
`● do not take more than directed
`Directions
`overdose, get medical help or contact a Poison Control Center right away.
`child or complications during delivery. Keep out of reach of children. In case of
`definitely directed to do so by a doctor because it may cause problems in the unborn
`important not to use naproxen sodium during the last 3 months of pregnancy unless
`If pregnant or breast-feeding, ask a health professional before use. It is especially
`● it feels like the capsule is stuck in your throat
`● you have difficulty swallowing
`● any new symptoms appear
`● redness or swelling is present in the painful area
`● fever gets worse or lasts more than 3 days
`● pain gets worse or lasts more than 10 days
`
`● slurred speech ● leg swelling
`● chest pain ● trouble breathing ● weakness in one part or side of body
`
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`● ask a doctor
`● do not exceed 3 capsules in a 24-hour period
`● do not exceed 2 capsules in any 8- to 12-hour period
` first hour
`● for the first dose you may take 2 capsules within the
` last
`● take 1 capsule every 8 to 12 hours while symptoms
`
`
`
`
`
`
`
`
`
`
`
`
`1-888-235-2466 (Mon - Fri 9AM -5PM EST)
`Questions or comments?
`polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
`FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink,
`Inactive ingredients
`● read all directions and warnings before use. Keep carton.
` 40˚C (104˚F)
`● store at 20-25˚C (68-77˚F) avoid high humidity and excessive heat above
`● each capsule contains: sodium 20 mg
`Other information
`children under 12 years:
`
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`● you experience any of the following signs of stomach bleeding:
`Stop use and ask a doctor if
`● take with food or milk if stomach upset occurs
`When using this product
`Drug Facts (continued)
`
`
`
`Reference ID: 4567251
`
`
`
`
`
`
`
`
`
`
`
`● have stomach pain that does not get better
`● feel faint ● vomit blood ● have bloody or black stools
`
`● you have symptoms of heart problems or stroke:
`
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`

`

`Manufactured for: BIONPHARMA
`***This product is not manufactured or distributed by the owners of ALEVE® Liquid Gels.
`
`
`
`R0519
`L0000000
`600 Alexander Road, Princeton, NJ 08540
`
`Lot/EXP
`
`Front
`
`● menstrual cramps
`
`Drug Facts
`Purposes
`Active ingredient (in each capsule)
`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:
`
`● minor pain of arthritis
`● backache
`● muscular aches
`● 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 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 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 surgery
`
`Do not use if printed safety seal under cap is torn or missing.
`
`Back
`
`2.375”
`
`NDC 69452-179-25
`
`Be
`Health
`Compare to the active ingredient
`***
`in ALEVE® Liquid Gels
`
`Naproxen Sodium
`Capsules, 220 mg
`(NSAID)
`
`Pain reliever/fever reducer
`
`Strength to last 12 hours
`180 Capsules**
`
`**Liquid-filled capsule
`
`● ask a doctor
`● do not exceed 3 capsules in a 24-hour period
`● do not exceed 2 capsules in any 8- to 12-hour period
`older:
`hour
`years and
`● for the first dose you may take 2 capsules within the first
`children 12
`● take 1 capsule every 8 to 12 hours while symptoms last
`adults and
`each dose ● if taken with food, this product may take longer to work
`effective dose should be used ● drink a full glass of water with
`Directions ● do not take more than directed ● the smallest
`contact a Poison Control Center right away.
`Keep out of reach of children. In case of overdose, get medical help or
`during delivery.
`because it may cause problems in the unborn child or complications
`months of pregnancy unless definitely directed to do so by a doctor
`is especially important not to use naproxen sodium during the last 3
`If pregnant or breast-feeding, ask a health professional before use. It
`swallowing ● it feels like the capsule is stuck in your throat
`painful area ● any new symptoms appear ● you have difficulty
`or lasts more than 3 days ● redness or swelling is present in the
`● pain gets worse or lasts more than 10 days ● fever gets worse
`of body ● slurred speech ● leg swelling
`● chest pain ● trouble breathing ● weakness in one part or side
`● you have symptoms of heart problems or stroke:
`
`-5PM EST)
`Questions or comments? 1-888-235-2466 (Mon - Fri 9AM
`glycol, purified water, sorbitan, sorbitol
`mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene
`Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic acid,
`above 40˚C (104˚F) ● read all directions and warnings before use.
`● store at 20-25˚C (68-77˚F) avoid high humidity and excessive heat
`Other information ● each capsule contains: sodium 20 mg
`12 years:
`under
`children
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`● have stomach pain that does not get better
`● feel faint ● vomit blood ● have bloody or black stools
`● you experience any of the following signs of stomach bleeding:
`Stop use and ask a doctor if
`occurs
`When using this product ● take with food or milk if stomach upset
`● taking any other drug
`attack or stroke, because naproxen may decrease this benefit of aspirin
`doctor's care for any serious condition ● taking aspirin for heart
`Ask a doctor or pharmacist before use if you are ● under a
`or fever reducers
`● you have problems or serious side effects from taking pain relievers
`disease, asthma, or had a stroke ● you are taking a diuretic
`● you have high blood pressure, heart disease, liver cirrhosis, kidney
`you ● you have a history of stomach problems, such as heartburn
`Ask a doctor before use if ● stomach bleeding warning applies to
`Drug Facts (continued)
`
`
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`BIONPHARMA
`Labeling Format Information:
`Fonts: Helvetica Condensed Bold, Helvetica Condensed,
`Helvetica Condensed Bold Oblique
`
`
`Drug Facts:
`9pt
`Header:
` 8pt
`
`Subheader:
`6pt
`
`
`Body Text:
`6pt
`
`Drug Facts (continued): N/A
`
`Leading:
`Bullets:
`Barlines:
`Hairlines:
`
`
`
`6.5pt
` 5pt
`2pt
`
`.5pt
`
`Horizontal Scale: 85%
`
`Average Kerning: 0%
`
`Reference ID: 4567251
`
`Imprint/NV Area
`0.5000"
`
`Imprint/NV Area
`
`1.9532"
`
`R 0.1250"
`
`2.3750"
`
`6.2500"
`
`Hinge/NV Area
`1.0000"
`
`2.3750"
`
`6.2500"
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`02/27/2020 06:13:32 PM
`
`Reference ID: 4567251
`
`(
`
`
`
`