Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Regular Strength Acetaminophen (NDC 41226-340). 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
temporarily relieves minor aches and pains due to:
temporarily reduces fever
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 the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use 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.
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.
Directions
Do not take more than directed.
See overdose warning
| adults and children 12 years and over |
|
| children 6 years to under 12 years |
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| 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? 1-800-632-6900
* Please review the disclaimer below.