Naproxen Sodium by Western Family Foods, Inc. Drug Facts
Naproxen Sodium by
Drug Labeling and Warnings
Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NAPROXEN SODIUM- naproxen sodium capsule, liquid filled
Western Family Foods, Inc.
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Drug Facts
Active ingredient (in each capsule)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- minor pain or arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever
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
- 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, 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
- under a doctor’s care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- 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
- 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 appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
- adults and children 12 years and older:
- take 1 capsule every 8 to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8- to 12-hour period
- do not exceed 3 capsules in a 24-hour period
- children under 12 years: ask a doctor
Other information
- each capsule contains: sodium 20 mg
- swallow whole: do not crush, chew or dissolve
- store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
Inactive ingredients
FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol 600, povidone K30, propylene glycol, purified water, sorbitan, sorbitol
Principal Display Panel
†Compare to the active ingredient in Aleve® Liquid Gels
Naproxen sodium
capsules, 220 mg (NSAID)
pain reliever/fever reducer
strength to last 12 hours
Liquid gels**
**Liquid filled capsules
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION.
†This product is not manufactured or distributed by Bayer HealthCare, LLC, owner of the registered trademark Aleve® Liquid Gels.
Proudly Distributed by Western Family Foods, inc.
P.O Box 4057, Portland, OR 97208 USA
| NAPROXEN SODIUM
naproxen sodium capsule, liquid filled |
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| Labeler - Western Family Foods, Inc. (192166072) |