acetaminophen

Manufacturer
DIRECT RX
Effective date
2022-03-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:06:41

Label at a glance#

Productacetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Storage and handling

Other information store at room temperature in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever.

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
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 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

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

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.

DOSAGE & ADMINISTRATION SECTION

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over

take 2 tablets every 4 to 6 hours while symptoms last
do not take more than 10 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children 6 years to under 12 years

take 1 tablet every 4 to 6 hours, while symptoms last
do not take more than 5 tablets in 24 hours
do not use for more than 5 days unless directed by a doctor

children under 6 years ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at room temperature in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

Manufactured in a GMP facility in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

197197

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

247247

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fhtyfghfhtyfgh

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-197-30EA - Each72189-1973383a4d5-64f2-4eb4-b953-aad313b4b26712021-06-02
72189-247-30EA - Each72189-247484b0a0e-ea30-4522-90b9-1d09064301c512021-08-05
72189-247-71EA - Each72189-24734433428-ee5e-4bff-a133-e836443c8a2c12022-04-06
51645-703-01EA - Each51645-7031c8a57e7-e5ec-4f20-9653-a270349a753212021-11-09
57896-104-01EA - Each57896-1049c729477-9f92-45a4-9237-ba204105dab912023-06-06
57896-104-10EA - Each57896-104912af808-5ba7-4a40-9353-9a868e25569d12021-05-05
57896-104-20EA - Each57896-104cd916e63-66db-4bb5-97b2-9c366aee75d612021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72189-19772189-197-30
72189-24772189-247-30, 72189-247-71
51645-703
57896-104

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
074b6340-0485-ab05-e063-6294a90adedbc10b207e-27df-ea5e-e053-2995a90a8db42023-10-09WarningsExact identifier
spl set id: c10b207e-27df-ea5e-e053-2995a90a8db4

Reported adverse events (FAERS/openFDA)#

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