The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredient (In Each Softgel)
Acetaminophen 500 mg
Pain reliever/ fever reducer
■ 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
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 a 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - Stop Use
■ 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 even if you do not notice any signs or symptoms.
Do not take more than directed (see
Adults and children 12 years and over ■ take 2 softgels every 6 hours while
■ do not take more than 6 softgels in
24 hours unless directed by a doctor
■ do not use for more than 10 days
unless directed by a doctor
ask a doctor
each softgel contains: sodium 7 mg
■ store between 15°-30°C (59°-86°F)
FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,
potassium hydroxide, povidone, propylene glycol, purified
water, sodium hydroxide, sorbitol, sorbitol sorbitan solution
Otc - Questions
Questions or Comments? 1-888-333-9792
* Please review the disclaimer below.