Label: EQUATE NAPROXEN SODIUM- naproxen sodium capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-098-27 - Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 25, 2014
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- Active ingredient (in each capsule)
- 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:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- the stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have asthma
Ask a doctor or pharmacist before use if you are
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- under a doctor’s care for any serious condition
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- taking any other drug
When using this product
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- take with food or milk if stomach upset occurs
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- 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
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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- you have difficulty swallowing
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- it feels like the capsule is stuck in your throat
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- drink a full glass of water with each dose
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- if taken with food, this product may take longer to work
adults and children 12 years and older:
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- take 1 capsule every 8 to 12 hours while symptoms last
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- for the first dose you may take 2 capsules within the first hour
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- do not exceed 2 capsules in any 8- to 12-hour period
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- do not exceed 3 capsules in a 24-hour period
children under 12 years:
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- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
EQUATE NAPROXEN SODIUM
naproxen sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-098 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. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE (Clear) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 742 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-098-27 80 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021920 08/09/2013 Labeler - Wal-Mart Stores Inc (051957769)