Country: United States
Language: English
Source: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Belmora LLC
ORAL
OTC DRUG
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: toothache muscular aches backache the common cold headache menstrual cramps minor pain of arthritis - toothache - muscular aches - backache - the common cold - headache - menstrual cramps - minor pain of arthritis - temporarily reduces fever
Abbreviated New Drug Application
FLANAX MENSTRUAL PAIN RELIEVER- NAPROXEN SODIUM TABLET, FILM COATED BELMORA LLC ---------- FLANAX 44-604 _ACTIVE INGREDIENT (IN EACH CAPLET)_ Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug _PURPOSE_ Pain reliever/fever reducer _USES_ temporarily relieves minor aches and pains due to: toothache muscular aches backache the common cold headache menstrual cramps minor pain of arthritis temporarily reduces fever _WARNINGS_ ALLERGY ALERT: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) shock facial swelling rash hives skin reddening 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 take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product 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. 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 you are taking a diuretic the stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have a history of stomach problems, such as heartburn you have problems or serious side effects from taking pain relievers or fever reducers ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin Read the complete document