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.
Otc - Active Ingredient
Active ingredient (in each tablet) Acetaminophen 325 mg.
Otc - Purpose
PurposePain reliever/fever reducer
Indications & Usage
Usestemporarily relieves minor aches and pains due to:■ headache■ muscular aches■ backache■ minor pain of arthritis■ the common cold■ toothache■ premenstrual and menstrual crampstemporarily reduces fever
WarningsLiver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
■ adult takes more than 4,000 mg of acetaminophen in 24 hours■ child takes more than 5 doses in 24 hours, which is the maximum daily amount■ taken with other drugs containing acetaminophen■ adult has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening■ blisters■ rashIf a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
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 ifthe user has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Otc - Stop Use
Stop using and ask a doctor if■ pain gets worse or lasts more than 10 days in adults■ pain gets worse or lasts more than 5 days in children under 12 years■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness or swelling is presentThese 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.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 even if you do not notice any signs or symptoms.
Dosage & Administration
Directions■ do not use more than directed (see overdose warning)Adults and children 12 years and over ■ take 2 tablets every 4 to 6 hours while symptoms last
■ do not take more than 10 tablets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
Children 6 years to under 12 years ■ take 1 tablet every 4 to 6 hours while symptoms last
■ do not take more than 5 tablets in 24 hours ■ do not use for more than 5 days unless directed by a doctor
Children under 6 years ask a doctor
Other Safety Information
Other information■ store at room temperature 59º-86ºF (15º-30ºC)■
TAMPER EVIDENT child resistant packets
■ do not use any opened or torn packets
Inactive ingredientscorn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid, titanium dioxide** may contain
Otc - Questions
Questions or comments? 1-800-634-7600
* Please review the disclaimer below.