All Day Pain Relief Naproxen Sodium Naproxen Sodium SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN 141
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel NDC 68084-914-01 Naproxen Sodium Tablets, USP 220 mg Pain Reliever / Fever Reducer (NSAID) STRENGTH TO LAST 12 HOURS 100 Tablets (10 x 10) Naproxen Sodium Tablets, USP 220 mg Label
- Principal Display Panel NDC 68084-914-01 Naproxen Sodium Tablets, USP 220 mg Pain Reliever / Fever Reducer (NSAID) STRENGTH TO LAST 12 HOURS 100 Tablets (10 x 10) Naproxen Sodium Tablets, USP 220 mg Label
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 Adults and children 12 years and older: take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within 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
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 blisters skin reddening rash 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 pill 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 pill 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 Store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F) each tablet contains: sodium 20 mg FOR YOUR PROTECTION: Do not use product if blister is torn or broken Side effects occur. You may report side effects to FDA at 1-800-FDA-1088 Supplied as unit dose packages of 100 (10 x 10) NDC 68084-914-01
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