- Active ingredient (in each caplet)
- 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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- Do not use
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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 have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
- you are taking a diuretic
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- 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 appea
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
- you experience any of the following signs of stomach bleeding:
- If pregnant or breast-feeding,
- 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 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- to 12- hour period
- do not exceed 3 caplets in a 24- hour period
- children under 12 years: ask a doctor
Other information
- each caplet contains:sodium 20 mg
- store at 20o to 25o C (68 to77°F). Avoid high humidity and excessive heat above 40°C (104°F)
- read all warnings and directions before use. Keep carton.
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Principal Display Panel
Compare to Aleve® active ingredient**
**This product is not manufactured or distributed by Bayer Healthcare, LLC., owner of the registered trademark Aleve®
Naproxen Sodium tablets, 220 mg
Pain Reliever/ Fever Reducer (NSAID)
Strength to last 12 hours
†Caplets
†capsule shaped tablets
DO NOT USE IF INNER SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
- Product Label
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-068 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 12mm Flavor Imprint Code I7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-068-30 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2014 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079096 02/12/2014 12/30/2021 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)