Otc - Active Ingredient
Active ingredient
(in each caplet)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Acetaminophen (NDC 41226-341). 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 caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
headache
the common cold
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
Warnings
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.
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 use and ask a doctor if
These could be signs of a seroius condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
do not take more than directed
adults and children 12 years and over
children under 12 years ask a doctor
Other information
Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide
*may contain this ingredient
Questions or comments?
1-800-632-6900
* Please review the disclaimer below.