Bayer Healthcare LLC, distributor of ALEVE® Liquid Gels.
`***This product is not manufactured or distributed by
`
`1-888-235-2466 (Mon-Fri 9AM – 5PM EST)
`Questions or comments?
`propylene glycol, purified water, sorbitan, sorbitol
`acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone,
`Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic
`● read all directions and warnings before use. Keep carton.
` heat above 40˚C (104˚F)
`● store at 20-25˚C (68-77˚F) avoid high humidity and excessive
`● each capsule contains: sodium 20 mg
`Other information
`12 years:
`children under
`
`● ask a doctor
`● do not exceed 3 capsules in a 24-hour period
` 12-hour period
`● do not exceed 2 capsules in any 8- to
`older:
` within the first hour
`years and
`● for the first dose you may take 2 capsules
`children 12
` symptoms last
`adults and
`● take 1 capsule every 8 to 12 hours while
`● 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
`Center right away.
`In case of overdose, get medical help or contact a Poison Control
`complications during delivery. Keep out of reach of children.
`by a doctor because it may cause problems in the unborn child or
`the last 3 months of pregnancy unless definitely directed to do so
`use. It is especially important not to use naproxen sodium during
`If pregnant or breast-feeding, ask a health professional before
`● it feels like the capsule is stuck in your throat
`● any new symptoms appear ● you have difficulty swallowing
`● 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
` of body ● slurred speech ● leg swelling
` ● chest pain ● trouble breathing ● weakness in one part or side
`● you have symptoms of heart problems or stroke:
` ● 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
`Drug Facts (continued)
`
`● take with food or milk if stomach upset occurs
`When using this product
`● taking any other drug
`● under a doctor's care for any serious condition
`Ask a doctor or pharmacist before use if you are
` relievers or fever reducers
`● you have problems or serious side effects from taking pain
`● you are taking a diuretic
` kidney disease, asthma, or had a stroke
`● you have high blood pressure, heart disease, liver cirrhosis,
`● 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
` reliever/fever reducer
`● if you have ever had an allergic reaction to any other pain
`Do not use
`risk is higher if you use more than directed or for longer than directed.
`risk of heart attack, heart failure, and stroke. These can be fatal. The
`Heart attack and stroke warning: NSAIDs, except aspirin, increase the
`● take more or for a longer time than directed
`● have 3 or more alcoholic drinks every day while using this product
` NSAIDs (aspirin, ibuprofen, naproxen, or others)
`● take other drugs containing prescription or nonprescription
`● take a blood thinning (anticoagulant) or steroid drug
`● have had stomach ulcers or bleeding problems
`● are age 60 or older
`may cause severe stomach bleeding. The chance is higher if you:
`Stomach bleeding warning: This product contains an NSAID, which
`right away.
`If an allergic reaction occurs, stop use and seek medical help
`● shock ● skin reddening ● rash
`● blisters
`● hives ● facial swelling ● asthma (wheezing)
`especially in people allergic to aspirin. Symptoms may include:
`Allergy alert: Naproxen sodium may cause a severe allergic reaction,
`Warnings
`● temporarily reduces fever
` ● the common cold
`● toothache
` ● headache
`● menstrual cramps
` ● backache
`● muscular aches
` ● 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
`Active ingredient (in each capsule) Purposes
`Drug Facts
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Compare to the active ingredient
`of ALEVE® Liquid Gels***
`
`Strength to last 12 hours
`
`2 PACK 2 x 80 CT
`
`2 PACK 2 x 80 CT
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`Strength to last 12 hours
`
`Compare to the active ingredient
`of ALEVE® Liquid Gels***
`
`Naproxen Sodium
`Capsules, 220 mg
` (NSAID)
`Pain Reliever/Fever Reducer
`
`2 PACK
`2 x 80 CT
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reiever/Fever Reducer
`
`Strength to last 12 hours
`
`Strength to last 12 hours
`
`160 CAPSULES
`
`80 Capsules
`
`160 CAPSULES
`
`80 Capsules
`
`Strength to last
`12 hours
`
`160 CAPSULES
`
`2 Bottles x 80 Capsules Each
`
`Strength to last
`12 hours
`
`Manufactured for:
`Bionpharma Inc.
`600 Alexander Road,
`Princeton, NJ 08540
`
`0119
`
`Naproxen Sodium
`Capsules, 220 mg
` (NSAID)
`Pain Reliever/Fever Reducer
`
`2 PACK
`2 x 80 CT
`
`Do not use if printed safety seal
`under cap is torn or missing.
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reiever/Fever Reducer
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Strength to last 12 hours
`
`Strength to last 12 hours
`
`160 CAPSULES
`
`80 Capsul s
`
`160 CAPSULES
`
`80 Capsules
`
`Rev # 08/18
`
`Lot No.:
`
`Exp. Date:
`
`LOT & EXP
`
`Reference ID: 4393224
`
`(b) (4)
`
`

`

`1-888-235-2466 (Mon-Fri 9AM – 5PM EST)
`Questions or comments?
`propylene glycol, purified water, sorbitan, sorbitol
`acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone,
`Inactive ingredients FD&C blue #1, gelatin, glycerin, lactic
`● read all directions and warnings before use. Keep carton.
` heat above 40˚C (104˚F)
`● store at 20-25˚C (68-77˚F) avoid high humidity and excessive
`● each capsule contains: sodium 20 mg
`Other information
`12 years:
`children under
`
`● ask a doctor
`● do not exceed 3 capsules in a 24-hour period
` 12-hour period
`● do not exceed 2 capsules in any 8- to
`older:
` within the first hour
`years and
`● for the first dose you may take 2 capsules
`children 12
` symptoms last
`adults and
`● take 1 capsule every 8 to 12 hours while
`● 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
`Center right away.
`In case of overdose, get medical help or contact a Poison Control
`complications during delivery. Keep out of reach of children.
`by a doctor because it may cause problems in the unborn child or
`the last 3 months of pregnancy unless definitely directed to do so
`use. It is especially important not to use naproxen sodium during
`If pregnant or breast-feeding, ask a health professional before
`● it feels like the capsule is stuck in your throat
`● any new symptoms appear ● you have difficulty swallowing
`● 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
` of body ● slurred speech ● leg swelling
` ● chest pain ● trouble breathing ● weakness in one part or side
`● you have symptoms of heart problems or stroke:
` ● 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
`Drug Facts (continued)
`
`● take with food or milk if stomach upset occurs
`When using this product
`● taking any other drug
`● under a doctor's care for any serious condition
`Ask a doctor or pharmacist before use if you are
` relievers or fever reducers
`● you have problems or serious side effects from taking pain
`● you are taking a diuretic
` kidney disease, asthma, or had a stroke
`● you have high blood pressure, heart disease, liver cirrhosis,
`● 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
` reliever/fever reducer
`● if you have ever had an allergic reaction to any other pain
`Do not use
`risk is higher if you use more than directed or for longer than directed.
`risk of heart attack, heart failure, and stroke. These can be fatal. The
`Heart attack and stroke warning: NSAIDs, except aspirin, increase the
`● take more or for a longer time than directed
`● have 3 or more alcoholic drinks every day while using this product
` NSAIDs (aspirin, ibuprofen, naproxen, or others)
`● take other drugs containing prescription or nonprescription
`● take a blood thinning (anticoagulant) or steroid drug
`● have had stomach ulcers or bleeding problems
`● are age 60 or older
`may cause severe stomach bleeding. The chance is higher if you:
`Stomach bleeding warning: This product contains an NSAID, which
`right away.
`If an allergic reaction occurs, stop use and seek medical help
`● shock ● skin reddening ● rash
`● blisters
`● hives ● facial swelling ● asthma (wheezing)
`especially in people allergic to aspirin. Symptoms may include:
`Allergy alert: Naproxen sodium may cause a severe allergic reaction,
`Warnings
`● temporarily reduces fever
` ● the common cold
`● toothache
` ● headache
`● menstrual cramps
` ● backache
`● muscular aches
` ● 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
`Active ingredient (in each capsule) Purposes
`Drug Facts
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Strength to last 12 hours
`
`2 PACK 2 x 80 CT
`
`2 PACK 2 x 80 CT
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Strength to last 12 hours
`
`Naproxen Sodium
`Capsules, 220 mg
` (NSAID)
`Pain Reliever/Fever Reducer
`
`2 PACK
`2 x 80 CT
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reiever/Fever Reducer
`
`Strength to last 12 hours
`
`Strength to last 12 hours
`
`160 CAPSULES
`
`80 Capsules
`
`160 CAPSULES
`
`80 Capsules
`
`Strength to last
`12 hours
`
`160 CAPSULES
`
`2 Bottles x 80 Capsules Each
`
`Strength to last
`12 hours
`
`Manufactured for:
`Bionpharma Inc.
`600 Alexander Road,
`Princeton, NJ 08540
`
`0119
`
`Naproxen Sodium
`Capsules, 220 mg
` (NSAID)
`Pain Reliever/Fever Reducer
`
`2 PACK
`2 x 80 CT
`
`Do not use if printed safety seal
`under cap is torn or missing.
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reiever/Fever Reducer
`
`Naproxen Sodium
`Capsules, 220 mg (NSAID)
`Pain Reliever/Fever Reducer
`
`Strength to last 12 hours
`
`Strength to last 12 hours
`
`160 CAPSULES
`
`80 Capsul s
`
`160 CAPSULES
`
`80 Capsules
`
`Rev # 08/18
`
`Lot No.:
`
`Exp. Date:
`
`LOT & EXP
`
`Reference ID: 4393224
`
`(b) (4)
`
`

`

`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
`02/20/2019 05:05:43 PM
`
`Reference ID: 4393224
`
`(
`
`
`
`