FLANAX MENSTRUAL PAIN RELIEVER- naproxen sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Available from:

Belmora LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                FLANAX MENSTRUAL PAIN RELIEVER- NAPROXEN SODIUM TABLET, FILM COATED
BELMORA LLC
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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
                                
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