naproxen sodium Naproxen sodium NAPROXEN SODIUM NAPROXEN FD&C BLUE NO. 1 GELATIN GLYCERIN LACTIC ACID MANNITOL POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL WATER SORBITAN SORBITOL Clear 742 Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

naproxen sodium Naproxen sodium NAPROXEN SODIUM NAPROXEN FD&C BLUE NO. 1 GELATIN GLYCERIN LACTIC ACID MANNITOL POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL WATER SORBITAN SORBITOL Clear 742

Mfr: OTC
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Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients FD&C blue #1 gelatin glycerin lactic acid mannitol pharmaceutical ink polyethylene glycol povidone propylene glycol purified water sorbitan sorbitol
Strengths
220 mg 200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Muscular Aches Backache Menstrual Cramps Headache Toothache The Common Cold Temporarily Reduces Fever

Identifiers & Packaging

Container Type BOX
Packaging

Package/Label Principal Display Panel Compare to the active ingredient of Aleve® Liquid Gels NAPROXEN SODIUM CAPSULES, 220 mg (NSAID) Pain reliever/ Fever reducer Strength to last 12 hours †liquid filled capsules NOT ACTUAL SIZE, SEE SIDE PANEL (Used on packaging configurations containing an image of a broken capsule graphic only) Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image

Package Descriptions
  • Package/Label Principal Display Panel Compare to the active ingredient of Aleve® Liquid Gels NAPROXEN SODIUM CAPSULES, 220 mg (NSAID) Pain reliever/ Fever reducer Strength to last 12 hours †liquid filled capsules NOT ACTUAL SIZE, SEE SIDE PANEL (Used on packaging configurations containing an image of a broken capsule graphic only) Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image

Overview

Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

Indications & Usage

Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

Dosage & Administration

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

Warnings & Precautions
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 • 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 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 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 • vomit blood • have bloody or black stools • 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery

When Using

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 & Ask a Doctor

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 • 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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Storage & Handling

Other information • each capsule contains: sodium 20 mg • store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) • do not use if printed foil under cap is broken or missing • read all directions and warnings before use. Keep carton.

Questions

Questions or comments? 1-800-719-9260


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