Pain and Fever Relief Naproxen Sodium POLYSORBATE 80 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TALC MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED NAPROXEN SODIUM NAPROXEN STARCH, CORN TITANIUM DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 2 MAGNESIUM STEARATE WATER ET;9 (Light Blue)
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL Label
- PRINCIPAL DISPLAY PANEL 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 Adults and children 12 years and over ■ 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 hr 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. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
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
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 ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ redness of swelling is present in the painful area ■ any new symptoms appear You may report side effects to FDA at 1-800-FDA-1088
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.
Questions
QUESTIONS OR COMMENTS? Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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