Acetaminophen 325mg RS

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Acetaminophen 325mg RS
Generic name
ACETAMINOPHEN 325MG
Manufacturer
Allegiant Health
Product type
HUMAN OTC DRUG
SPL set ID
61c6d281-e59b-4277-bbce-f71c12c2a56d
SPL ID
92f2ab65-26c5-4e2e-9f13-1d7836c8d559
Version
4
Effective date
2019-01-07
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:47
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 adult takes more than 4,000mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin is a child with pain of arthritis Stop use and ask a doctor if Adult’s pain gets worse or lasts more than 10 days Child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.