acetaminophen

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:52:10

Label at a glance#

Productacetaminophen
Active ingredientACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:

-the common cold

-headache

-backache

-minor pain of arthritis

-toothache

-muscular aches

-premenstrual and menstrual cramps

  • temporarily reduces fever.

WARNINGS SECTION

Warnings

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

•more than 4,000 mg of acetaminophen in 24 hours
•with other drugs containing acetaminophen
•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.

OTC - DO NOT USE SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: 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 caplets every 6 hours while symptoms last

-do not take more than 6 caplets in 24 hours, unless directed by a doctor

-do not take for more than 10 days unless directed by a doctor

children under 12 years

-ask a doctor

OTHER SAFETY INFORMATION

Other information

  • SODIUM FREE
  • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients

hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate* stearic acid, titanium dioxide

*may contain this ingredient

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

341R-APAP 500mg 100ct_LABEL341R-APAP 500mg 100ct_LABEL

341R - Target 100ct IFC341R - Target 100ct IFC

341R - Target 500ct label (NFR)341R - Target 500ct label (NFR)

341R - Target 1000ct sleeve341R - Target 1000ct sleeve

341R - Target 50ct IFC341R - Target 50ct IFC

341R - Target 50ct label341R - Target 50ct label

341R - Target 225ct IFC341R - Target 225ct IFC

341R - Target 225ct label341R - Target 225ct label

341R - Target 500ct label341R - Target 500ct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN4
198440acetaminophen 500 MG Oral TabletSCD4
198440APAP 500 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-838-01acetaminophen100 in 1 BOTTLETABLET, COATED1004
11673-838-05acetaminophen50 in 1 BOTTLETABLET, COATED504
11673-838-10acetaminophen2 in 1 CARTONTABLET, COATED24
11673-838-26acetaminophen225 in 1 BOTTLETABLET, COATED2254
11673-838-50acetaminophen500 in 1 BOTTLETABLET, COATED5004

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-83811673-838-01, 11673-838-05, 11673-838-50, 11673-838-26, 11673-838-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-08-27full-release2026-06-01 00:22:06

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
acetaminophenACETAMINOPHENTARGET CORPORATION8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb2025-09-29WarningsExact identifier
ndc (package): 11673-838-01
ndc (package): 11673-838-10
ndc (package): 11673-838-26
ndc (package): 11673-838-50
ndc (package): 11673-838-05
ndc (product): 11673-838
ndc11 (package): 11673083826
ndc11 (package): 11673083805
ndc11 (package): 11673083810
ndc11 (package): 11673083801
ndc11 (package): 11673083850
spl id: 3feb273f-9713-576d-e063-6294a90aaad4
spl set id: 8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb

Reported adverse events (FAERS/openFDA)#

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