FDA Label for Naproxen Sodium

Other

Drug Facts

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.

Do not use if printed safety seal under cap is torn or missing.

***This product is not manufactured or distributed by the owners of ALEVE ^® Back & Muscle pain.

Manufactured for:

BIONPHARMA

600 Alexander Road
Princeton, NJ 08540

L0000387

R1020

Active Ingredient (In Each Capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

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
• redness or swelling is present in the painful area
• any new symptoms appear

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

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
children under 12 years:	ask a doctor

Other Information

• each capsule contains: sodium 20 mg
• store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
• protect from light
• read all directions and warnings before use.

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?

1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

Principal Display Panel - 180'S Bottle

***compare to the active ingredient in ALEVE® BACK & MUSCLE PAIN

NDC 69452-284-25

a+healthTM

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

180 capsules**

**liquid-filled capsule

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