Flanax Pain Reliever/Fever reducer 220 mg/1

Naproxen Sodium · TABLET, COATED · Belmora LLC

No Recall History

Plain English

Flanax Pain Reliever/Fever reducer is a prescription tablet, coated containing naproxen sodium at 220 mg/1, taken oral. Manufactured by Belmora LLC.

Key Facts

Brand Name: Flanax Pain Reliever/Fever reducer
Generic Name: Naproxen Sodium
NDC Code (Product): 27854-505
Manufacturer: Belmora LLC
Strength: 220 mg/1
Dosage Form: TABLET, COATED
Route: ORAL
Marketing Status: HUMAN OTC DRUG
Application #: ANDA090545
Drug Class: Anti-Inflammatory Agents; Non-Steroidal [CS]
Marketing Start: 05/15/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,873 reports

fatigue2,619 reports

off label use2,508 reports

pain2,446 reports

rash2,238 reports

arthralgia2,196 reports

diarrhoea2,195 reports

vomiting2,126 reports

condition aggravated2,100 reports

joint swelling2,057 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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

Dosage & Administration

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 to12 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

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. Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 ■ 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 appl…

Frequently Asked Questions

What is Flanax Pain Reliever/Fever reducer used for?

Flanax Pain Reliever/Fever reducer contains Naproxen Sodium. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Flanax Pain Reliever/Fever reducer a controlled substance?

Flanax Pain Reliever/Fever reducer is not classified as a controlled substance by the DEA.

What is the generic name for Flanax Pain Reliever/Fever reducer?

The generic name for Flanax Pain Reliever/Fever reducer is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Flanax Pain Reliever/Fever reducer 220 mg/1?

The NDC (National Drug Code) for Flanax Pain Reliever/Fever reducer 220 mg/1 is 27854-505, listed by Belmora LLC.

Product NDC

27854-505

Package NDC

27854-505-01

Other Naproxen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)