Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Regular Strength Acetaminophen (NDC 70000-0092). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
Warnings
Liver 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop using and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of accidental 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.
Directions
adults and children 12 years and over
children 6 years to under 12 years
children under 6 years
ask a doctor
Other information
Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient
Questions or comments? Call 1-877-290-4008
* Please review the disclaimer below.