Drug class
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Uses
Uses: for temporary relief of minor aches and pains due to: headache backache muscular aches arthritis pain colds flu fever toothache premenstrual and menstrual cramps Temporarily relieves runny nose sneezing itchy nose and throat
Warnings
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets in 24 hours, which is the maximum daily amount 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. with any other product containing diphenhydramine, even one used on skin If you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if your are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery. Stop use and ask a doctor if pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. These may be signs of a serious condition. If you are pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.
Dosage & administration
Directions Adults and children 12 years of age and older: take 2 caplets every 6 hours. Maximum daily dose is 6 tablets. Children under 12 years of age: ask a doctor.
Active ingredient
Active Ingredient (in each caplet) Acetaminophen 500 mg
Inactive ingredient
Inactive i ngredients croscarmellose sodium, FD&C yellow no. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide, triacetin