Active Ingredient (In Each Caplet)
Naproxen sodium 220 mg
(naproxen 200 mg)
(NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Flanax Menstrual Pain Reliever (NDC 27854-165). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen sodium 220 mg
(naproxen 200 mg)
(NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
take with food or milk if stomach upset occurs
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Call 1-888-779-2877 M-F 9AM-5PM EST
NDC 27854-165-10
FLANAX®
MENSTRUAL
PAIN RELIEVER
Naproxen Sodium Tablets,
220 mg
PAIN RELIEVER/FEVER REDUCER
(NSAID)
10 ι CAPLETS
UP TO 12 HOURS
of menstrual pain relief
WWW.FLANAXUSA.COM
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by Belmora LLC
2231 Crystal Dr. #1000
Arlington, VA 22202 www.flanaxusa.com
* Please review the disclaimer below.