Label: NAPROXEN ALL DAY RELIEF FOR PAIN- naproxen sodium 220 mg tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69168-361-50 - Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 23, 2014
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- Active ingredient
- Purpose
- Uses
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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 awayStomach 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 surgeryAsk a 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 a doctor or pharmacist before use if you are
under a doctors care for any serious condition ■ taking any other 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: 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 - Keep Out of Reach of Children
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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 8-12 hour period do not exceed 3 tablets in a 24-hour period Children under 12 years: ask a doctor - Other Information
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
NAPROXEN ALL DAY RELIEF FOR PAIN
naproxen sodium 220 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-361 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 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 Color BLUE Score no score Shape ROUND Size 10mm Flavor Imprint Code 141 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-361-50 50 in 1 CARTON; Type 0: Not a Combination Product 12/23/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 12/23/2014 Labeler - Allegiant Health (079501930) Registrant - Allegiant Health (079501930) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 ANALYSIS(69168-361) , MANUFACTURE(69168-361) , LABEL(69168-361) , PACK(69168-361) , RELABEL(69168-361) , REPACK(69168-361)