Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Acetaminophen (NDC 82568-0001). 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, overdosage, other safety information, inactive ingredient, otc - questions, 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
To reduce fever and for the temporary relief of minor aches and pains due to:
•headache
•muscular aches
•backache
•minor pain of arthritis
•the common cold
•toothache
•premenstrual and menstrual cramps.
•Temporarily reduces fever.
Warnings
Liver warning:
This product contains acetaminophen. 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
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:
Taking more than the recommended dose (overdose) may cause liver damage. 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.
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children 6-11 years |
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child under 6 years | ask a doctor |
Other information
Inactive Ingredients:
Questions or comments?
call toll-free 1-877-225-6999.
Manufactured for:
AARNA USA INC.
Leland, NC-28451
* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.
* Please review the disclaimer below.