ALL DAY PAIN RELIEF NAPROXEN SODIUM- naproxen sodium tablet 
American Health Packaging

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NAPROXEN SODIUM TABLETS, USP

Pain reliever/Fever reducer (NSAID)



8291401/0515



Drug Facts

Active ingredient (in each tablet)

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

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

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

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
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat

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. (1-800-222-1222)

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

  • Store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • each tablet contains: sodium 20 mg
  • FOR YOUR PROTECTION: Do not use product if blister is torn or broken
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088
  • Supplied as unit dose packages of 100 (10 x 10) NDC 68084-914-01

Inactive ingredients

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

PACKAGING INFORMATION

American Health Packaging unit dose blisters contain drug product from Camber Consumer Care, Inc. as follows:
(220 mg/100 UD) NDC 68084-914-01 packaged from NDC 69230-141

Packaged and Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

Principal Display Panel

Naproxen Sodium Tablets, USP 220 mg Label

NDC 68084-914-01

Naproxen Sodium Tablets, USP 220 mg
Pain Reliever / Fever Reducer
(NSAID)

STRENGTH TO LAST 12 HOURS

100 Tablets (10 x 10)

ALL DAY PAIN RELIEF NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-914(NDC:69230-141)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68084-914-01100 in 1 BOX, UNIT-DOSE06/05/201506/30/2017
1NDC:68084-914-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054506/05/201506/30/2017
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(68084-914)

Revised: 2/2017
Document Id: 490d7210-4c81-47d8-e054-00144ff88e88
Set id: 75419151-c18a-4cb5-8cb0-e6e66abb4678
Version: 2
Effective Time: 20170221
 
American Health Packaging