FDA
Naproxen Sodium
The FDA lists this product in 60 strengths and forms.
Indications
USE(S)
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- headache
- the common cold
- menstrual cramps
- toothache
- temporarily reduces fever
Warnings and precautions
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
PREGNANCY/BREASTFEEDING If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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
- Hetero Labs LTD V
- Status
- Over the counter
- FDA approval
- 28 Oct 2022
- Application
- ANDA211065-001



