FDA.reportPublic FDA data

Acetaminophen

Manufacturer
A-S Medication Solutions
Effective date
2023-02-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:37:57

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/ Fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily reduces fever and relieves minor aches and pains due to:

  • headache 
  • muscular aches 
  • backache 
  • minor pain of arthritis
  • common cold 
  • toothache 
  • premenstrual and menstrual cramps

WARNINGS SECTION

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 4,000 mg 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 

OTC - DO NOT USE SECTION

  • 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 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.

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.

Overdose warning

OVERDOSAGE SECTION

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. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

OTHER SAFETY INFORMATION

store at room temperature

INACTIVE INGREDIENT SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed By: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4273

NDC: 50090-4273-0 1 TABLET in a BLISTER PACK / 30 in a BOX, UNIT-DOSE

Acetaminophen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4273-02023-02-07C16284748780-1f386c64a-2aee-0266-e053-dadaa90a7c1a0220K- Major
50090-4273-02023-01-30C16284748780-1f386c64a-2aee-0266-e053-dadaa90a7c1a0220K- Major

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4273-0EA - Each50090-42734a572321-c401-4114-a055-384e8ff7062a12022-04-06
0904-6773-61EA - Each0904-6773eeb743d0-c240-4234-83f6-e86f395e6e6412019-02-13

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-427350090-4273-0
0904-6773

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
ndc (product): 0904-6773
193dbc9d-0b98-4453-ab31-a055e48f58def49313be-2567-40de-8ae1-78fb28646b992025-01-08WarningsExact identifier
spl set id: f49313be-2567-40de-8ae1-78fb28646b99

Reported adverse events (FAERS/openFDA)#

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