FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Global Pharm Distribution LLC
Effective date
2020-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:46:32

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure7 sections

Indications and uses

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

Dosage and administration

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. do not take more than 10 days unless directed by a doctor. Children under 12 years: ask a doctor.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Corn Starch, Magnesium Stearate, Sodium Starch Glycolate, PVP.

USES:

INDICATIONS & USAGE SECTION

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

WARNINGS:

WARNINGS SECTION

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

  • more than 4000 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 a 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:

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen - if you are not sure whether a drug contains acetaminophen - ask a doctor or pharmacist
  • for more than 10 days for pains unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • liver disease.

Ask a doctor before use if 

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 days
  • ever gets worse or lasts more than 3 days
  • redness or swelling is present. These could be signs of a serious condition.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not noti ce any signs or symptoms.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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.
  • do not take more than 10 days unless directed by a doctor.

Children under 12 years: ask a doctor.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Store at 20 - 25°C (68 - 77°F).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69477-000-012025-06-25C16284748780-1f386c649-a719-0266-e053-dadaa90a7c1aAcetaminophen
69477-000-012023-01-30C16284748780-1f386c649-a719-0266-e053-dadaa90a7c1aAcetaminophen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69477-000ACETAMINOPHEN TABLET [GLOBAL PHARM DISTRIBUTION LLC]2Legacy NDC20200111_7b1c6ca4-f300-5cd0-e053-2991aa0a7ea8.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69477-00069477-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT

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
3868bd32-db87-f58d-e063-6394a90a4abb7b1c6ca4-f300-5cd0-e053-2991aa0a7ea82025-06-25WarningsExact identifier
spl set id: 7b1c6ca4-f300-5cd0-e053-2991aa0a7ea8

Reported adverse events (FAERS/openFDA)#

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