naproxen sodium
Drug Details
- Generic Name
- naproxen sodium
- Brand Names
- good sense naproxen sodium, Naproxen Sodium, Naproxen sodium, topcare back and muscle pain, betr headache pain relief, up and up naproxen sodium, naproxen sodium, Aleve, DG Health Naproxen Sodium
- Application Number
- ANDA074661
- Sponsor
- L. Perrigo Company
- NDC Codes
- 12
- Dosage Forms
- TABLET, FILM COATED, TABLET, FILM COATED, EXTENDED RELEASE, CAPSULE, LIQUID FILLED, TABLET
- Routes
- ORAL
- Active Ingredients
- NAPROXEN SODIUM
Indications and Usage
Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever
Warnings
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ 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 ■ have had stomach ulcers or bleeding problems ■ take blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ take more or for a longer time than directed ■ have 3 or more alcoholic drinks every day while using this product. Do not use ■ right before or after heart surgery ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer 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 asthma ■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease ■ you have a problems or serious side effects from taking pain relievers or fever reducers ■ 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 ■ 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 ■ 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 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 (1-800-222-1222) right away.