NAPROXEN SODIUM tablet, film coated
Naproxen Sodium by
Drug Labeling and Warnings
Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient (in each tablet)
- Purposes
- 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 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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- taking any other drug
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
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
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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- to 12-hour period
- do not exceed 3 tablets in a 24-hour period
Children under 12 years
- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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HOW SUPPLIED
Product: 71335-1061
NDC: 71335-1061-1 20 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-2 30 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-3 40 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-4 50 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-5 60 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-6 14 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-7 100 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1061-8 90 TABLET, FILM COATED in a BOTTLE
- Naproxen Sodium 220mg Tablet
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 71335-1061(NDC:45802-490) 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light Blue) Score no score Shape ROUND Size 10mm Flavor Imprint Code L490 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 71335-1061-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 2 NDC: 71335-1061-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 3 NDC: 71335-1061-3 40 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 4 NDC: 71335-1061-4 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 5 NDC: 71335-1061-5 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 6 NDC: 71335-1061-6 14 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 7 NDC: 71335-1061-7 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 8 NDC: 71335-1061-8 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074661 04/11/2014 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-1061) , RELABEL(71335-1061)
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