NAPROXEN- naproxen sodium tablet

Naproxen by

Drug Labeling and Warnings

Naproxen by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)1

1 nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • minor pain of arthritis
  • backache
  • menstrual cramps
  • muscular aches
  • 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

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, or kidney disease
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• 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 pill 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.

Directions

• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose

• Adults and children 12 years and older:
  • take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
• Children under 12 years:
  • ask a doctor

Other information

• each tablet contains: sodium 20 mg
• store at room temperature. Avoid excessive heat above 40°C (104°F).
• read all warnings and directions before use. Keep carton

Inactive ingredients

FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm cst)

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Dist. by:
Medline Industries, Inc.

Mundelein, IL 60060

PRINCIPAL DISPLAY PANEL – 100 Tablet Bottle Carton

Medline

NDC53329-675-30

**Compare to the active ingredient in Aleve

Naproxen

Pain Reliever/

Fever Reducer (NSAID)

Strength to last 12 Hours

Naproxen Sodium Tablets

220 mg

100 Tablets – 220 mg each

INGREDIENTS AND APPEARANCE

NAPROXEN 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-675
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	ALEVE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-675-30	1 in 1 CARTON
1		100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020204	07/26/2002

Labeler - Medline Industries, Inc. (025460908)