Drug Facts
Active ingredient (in each tablet)
Acetaminophen 325 mg
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Acetaminophen (NDC 0904-6773). 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 drug facts, otc - purpose, uses, warnings, 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
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.
Ask a doctor before use if the user
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.
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.
Store in a dry place at 15˚ - 30˚C (59˚ - 86˚F).
This unit dose package is intended for institutional use only.
povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
1-800-231-4670
DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Rev. 02/26 M-29 Re-order No. 700993
MAJOR®
NDC 0904-6773-61
regular strength
acetaminophen tablets
acetaminophen 325 mg
pain reliever/fever reducer
100 tablets
(10 x 10) unit dose
* Please review the disclaimer below.