Naproxen Sodium (NSAID)
Naproxen Sodium · Tablet · Oral
Active ingredient
(in each tablet) Naproxen sodium USP, 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever
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: NSAID, 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.
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
Ask a doctor or pharmacist
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, kidney disease, asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug
When using this product
When using this product take with food or milk if stomach upset occurs
Stop use and 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 or swelling is present in the painful area any new symptoms appear
Pregnancy or breast-feeding
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.
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.
Directions
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older 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-hour period Children under 12 years ask a doctor Other information each tablet contains: sodium 20 mg store at 20 to 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredients
INACTIVE INGREDIENT croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide
Questions?
Questions or Comments? Call 1-877-835-5472 Monday through Friday 9 AM – 5 PM EST.
Label text from the FDA structured product label by Amneal Pharmaceuticals of New York LLC (revised Dec 31, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Naproxen Sodium in 2 products
Naproxen Sodium (NSAID) NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 53746-191 | Naproxen Sodium 220 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-192 | Naproxen Sodium 220 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
Frequently asked questions
What is Naproxen Sodium (NSAID) used for?
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever
Who makes Naproxen Sodium (NSAID)?
Naproxen Sodium (NSAID) is listed by 1 labeler in the FDA NDC directory, including Amneal Pharmaceuticals of New York LLC.