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Naproxen by Chain Drug Consortium

Medically reviewed on October 27, 2017

Dosage form: capsule
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Chain Drug Consortium
NDC Code: 68016-462

Drug Facts

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 doctor’s care for any serious condition ■ taking any other drug prescription drug

When using this product

take with food or milk if stomach upset occursthe 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 used drink 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

croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide.

Package/Label Principal Display Panel
NAPROXEN 
naproxen sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-462
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
POLYETHYLENE GLYCOLS 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POVIDONES 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint CodeNone
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-462-1450 CAPSULE in 1 BOX
2NDC:68016-462-20100 CAPSULE in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054510/27/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705LABEL(68016-462), MANUFACTURE(68016-462), PACK(68016-462), RELABEL(68016-462), REPACK(68016-462)

 
Chain Drug Consortium

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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