Drugplain

FLANAX .003 g/100g

Methyl Salicylate, Menthol, Capsaicin · LINIMENT · Belmora LLC

1 Recall on Record
Plain English

FLANAX is a liniment containing methyl salicylate, menthol, capsaicin at .003 g/100g, taken topical. Manufactured by Belmora LLC.

Key Facts

Brand Name
FLANAX
Generic Name
Methyl Salicylate, Menthol, Capsaicin
NDC Code (Product)
27854-499
Manufacturer
Belmora LLC
Strength
.003 g/100g
Dosage Form
LINIMENT
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
08/01/2024

Recall History

1 Recall on Record
Class III12/18/2012

Belmora LLC

Defective Container: Product lacks tamper evident breakaway band on cap.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective20,718 reports
pain19,126 reports
fatigue18,568 reports
nausea17,048 reports
headache15,550 reports
arthralgia13,153 reports
dyspnoea13,137 reports
vomiting12,784 reports
diarrhoea12,536 reports
off label use12,277 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 used for?

FLANAX contains Methyl Salicylate, Menthol, Capsaicin. It is a liniment taken topical. Consult your doctor for specific uses.

Is FLANAX a controlled substance?

FLANAX is not classified as a controlled substance by the DEA.

What is the generic name for FLANAX?

The generic name for FLANAX is Methyl Salicylate, Menthol, Capsaicin. There are 11 other brand versions of Methyl Salicylate, Menthol, Capsaicin.

What is the NDC code for FLANAX .003 g/100g?

The NDC (National Drug Code) for FLANAX .003 g/100g is 27854-499, listed by Belmora LLC.