- Active ingredient (in each tablet)
- 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 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
-
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
- When using this product
-
Stop use and ask doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have a stomach pain that dose 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
- you experience any of the following signs of stomach bleeding:
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children
-
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 to12 hours while symptoms last
- for first dose you may take 2 tablets with in 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
- Storage
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3223(NDC:57896-951) 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 GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 144 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3223-1 21 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2018 2 NDC:68071-3223-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 05/01/2012 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(68071-3223)