Active Ingredient (In Each Gelcap)
Acetaminophen 325 mg
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Acetaminophen (NDC 46122-430). 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 active ingredient (in each gelcap), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 gelcaps (3,250 mg) in 24 hours. 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.
liver disease.
taking the blood thinning drug warfarin.
These could be signs of a serious condition.
ask a health professional before use.
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.
corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac, stearic acid, titanium dioxide
1-800-426-9391
Good Neighbor Pharmacy®
NDC 46122-430-78
Compare to Regular Strength Tylenol® active ingredient*
REGULAR STRENGTH
Acetaminophen 325 mg
Pain Reliever/Fever Reducer
100 Gelcaps
325 mg Each
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed By
AmerisourceBergan
1300 Morris Drive
Chesterbrook, PA 19087
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*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Regular Strength Tylenol®.
50844 ORG051567812
* Please review the disclaimer below.