FDA
Naproxen Sodium
The FDA lists this product in 60 strengths and forms.
Indications
Uses temporarily relieves minor aches and pain due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever
Warnings and 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.
Pregnancy and breastfeeding
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.
Composition
- Active ingredients
- NAPROXEN SODIUM 220MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
At a glance
- Brand name
- Naproxen Sodium
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- LNK Intl Inc
- Status
- Over the counter
- FDA approval
- 23 Jan 2017
- Application
- ANDA204872-001



