NOVEX ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Herbion Pakistan (Pvt.) Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Pain reliever/fever reducer Uses: ■ temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps ■ temporarily reduces fever

Authorization status:

OTC monograph not final

Summary of Product characteristics

NOVEX ACETAMINOPHEN EXTRA STRENGTH- ACETAMINOPHEN TABLET, FILM COATED
HERBION PAKISTAN (PVT.) LTD
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen 500 mg
PURPOS E:
Pain reliever/fever reducer
US ES :
■ temporarily relieves minor aches and pains due to:
• the common cold
• headache
• backache
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps
■ temporarily reduces fever
WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: acetaminophen may cause severe skin reactions. Symptoms
may include: ■ skin reddening
■ blisters ■ rash
if skin reaction occurs. stop use and seek medical help right away.
DO NOT USE
■ with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
■if you are allergic to acetaminophen or any of the inactive
ingredients in this product
ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood
thinning drug warfarin
STOP USE AND ASK A DOCTOR IF
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
OVERDOSE WARNING: In case of overdose, get medical help or contact a
Poison Control Center right
away. (1-800-222-1222) Quick medical attention is critical for adults
as well as for children