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 500 mg
Otc - Purpose
PuropsePain reliever/fever reducer
Indications & Usage
Usestemporarily relieves minor aches and pains due to:■ the common cold■ headache■ backache■ minor pain of arthritis■ toothache■ muscular aches■ premenstrual and menstrual crampstemporarily reduces fever
WarningsLiver 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 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 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
Stop use and ask a doctor if■ pain gets worse or lasts more than for more than 10 days■ 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
do not use more than directed (see overdose warning)Adults and children 12 years and over ■ take 2 tablets every 6 hours while symptoms last. ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
Children under 12 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? 1-800-634-7680
* Please review the disclaimer below.