Naproxen tablet

Active ingredient

Naproxen sodium 220 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to: minor pain of arthritis backache headache
muscular aches menstrual cramps toothache 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 doctor before use if

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

Ask doctor/pharmacist before use if you are

under a doctors care for any serious condition taking any other drug prescription 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: you 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 immediately.

Directions

do not take more than directed the smallest effective dose should be useddrink a full glass
of water with each dose Adults and children 12 years and older: take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8-12 hour period do not exceed 3 caplets in a 24-hour period Children under 12 years: ask a doctor

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Ingredients and appearance - Product information

Naproxen tablet- Naproxen sodium

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68016-464
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Naproxen sodium ( UNII: 9TN87S3A3C)( Naproxen - UNII: 57Y76R9ATQ ) 220 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone, unspecified ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color blue Size 10 mm
Shape ROUND Score 1
Imprint Code None

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68016-464-14 50 in 1 BOX 2014/11/27
2 NDC: 68016-464-20 100 in 1 BOX 2014/11/27

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090545 USA 2014/11/27

Labeler - Chain Drug Consortium( 101668460)

Establishment

Name ID/FEI Business Operations
Chain Drug Consortium 101668460 label( 68016-464), manufacture( 68016-464), pack( 68016-464), relabel( 68016-464), repack( 68016-464)

Package/label principal display panel