Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Percogesic (NDC 63029-054). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses:, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if your are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 mg
Diphenhydramine HCl 12.5 mg
Pain reliever/fever reducer
Antihistamine
for temporary relief of minor aches and pains due to:
Temporarily relieves
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
These may be signs of a serious condition.
ask a health professional before use.
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.
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.
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
1-800-443-4908
* Please review the disclaimer below.