FDA.reportPublic FDA data

Acetaminophen gelcaps

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:52:14

Label at a glance#

ProductAcetaminophen gelcaps
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:

- headache

- muscular aches

- backache

- minor pain of arthritis

- the 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 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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor

OTHER SAFETY INFORMATION

Other information

  • each gelcap contains: sodium 1 mg
  • store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients croscarmellose sodium, colloidal anhydrous silica, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

673T 225ct_LBL673T 225ct_LBL673T 100ct_LBL673T 100ct_LBL673T 50ct_LBL673T 50ct_LBL673T 50ct_IFC673T 50ct_IFC

673T- Target Acetaminophen Gelcaps 24ct IFC673T- Target Acetaminophen Gelcaps 24ct IFC

673T- Target Acetaminophen Gelcaps 24ct Label673T- Target Acetaminophen Gelcaps 24ct 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-674-05Acetaminophen gelcaps1 in 1 CARTONTABLET14
11673-674-05Acetaminophen gelcaps50 in 1 BOTTLETABLET504
11673-674-34Acetaminophen gelcaps225 in 1 BOTTLETABLET2254
11673-674-42Acetaminophen gelcaps24 in 1 BOTTLETABLET244
11673-674-42Acetaminophen gelcaps1 in 1 CARTONTABLET14
11673-674-73Acetaminophen gelcaps100 in 1 BOTTLETABLET1004

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-67411673-674-05, 11673-674-34, 11673-674-73, 11673-674-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
POVIDONEFZ989GH94EIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN2G86QN327LIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-07-09full-release2026-06-01 01:06:54

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
Acetaminophen gelcapsACETAMINOPHENTARGET CORPORATION2ea1931e-334e-a551-e063-6394a90a03b92025-09-29WarningsExact identifier
ndc (package): 11673-674-34
ndc (package): 11673-674-05
ndc (package): 11673-674-42
ndc (package): 11673-674-73
ndc (product): 11673-674
ndc11 (package): 11673067473
ndc11 (package): 11673067405
ndc11 (package): 11673067434
ndc11 (package): 11673067442
spl id: 3fea737d-9911-6c9a-e063-6294a90a9664
spl set id: 2ea1931e-334e-a551-e063-6394a90a03b9

Reported adverse events (FAERS/openFDA)#

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