NAPROXEN SODIUM by ADVANCED FIRST AID, INC.
Dosage form: tablet
Ingredients: NAPROXEN SODIUM 2001
Labeler: ADVANCED FIRST AID, INC.
NDC Code: 67060-000
ACTIVE INGREDIENT IN EACH TABLET-
Naproxen 200 mg
(naproxen 200 mg)(NSAID)*
*nonsteroidal anti-inflammatory drug
pain reliever/fever reducer
Uses: temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headaches • toothache • temporarily reduces fever
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
Stomach Bleeding Warning: This product contains 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 for 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 or swelling is present in the painful area • any new symptoms appear
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 specifically 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.
Directions: • do not use more than directed • the smallest effective dose should be used • drink a full glass of water with each dose
Adults and children 12 years of age and older: • Take 1 tablet every 8 - 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.
Inactive Ingredients: FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, povidone, talc, titanium dioxide
naproxen sodium tablet
|Labeler - ADVANCED FIRST AID, INC. (114477180)|
|Registrant - ADVANCED FIRST AID, INC. (114477180)|
|ULTRA SEAL CORPORATION||085752004||pack(67060-000)|
|MARKSANS PHARMA LIMITED||925822975||manufacture(67060-000)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.