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
Drug FactsActive ingredient (in each caplet)Acetaminophen 500 mg
Otc - Purpose
Purpose:Pain reliever/fever reducer
Indications & Usage
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
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 ■ 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 productAsk a doctor before use if you have liver diseaseAsk a doctor or pharmacist before use if you are taking the blood thinning drug warfarinStop 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 presentThese could be signs of a serious condition.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 take more than directed (see overdose warning)adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last■ do not take more than 6 caplets in 24 hours. unless directed by a doctor■ do not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor
Other Safety Information
Other information■ store between 20-25°C (68-77°F)■ do not use if carton is opened or bottle inner seal is broken or missing
Inactive Ingredients:Croscarmellose Sodium, Lactose Monohydrate, Microcrystalline Cellulose 102, Povidone K30, Stearic Acid, Talc, Titanium Dioxide
Otc - Questions
Questions or Comments?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
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