FDA.reportPublic FDA data

Acetaminophen

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:20

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 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 6 hours while symptoms last • do not take more than 6 tablets 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Acetaminophen 500 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. 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

  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)

adults and children 12 years and over:

• take 2 tablets every 6 hours while symptoms last

• do not take more than 6 tablets 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 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

Call (800) 616-2471

SPL UNCLASSIFIED SECTION

SAVE CARTON FOR COMPLETE DRUG FACTS

Do not use if carton is open or if imprinted safety seal under cap is broken or missing.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2758-22025-01-30C16284748780-12cef2736-7126-d83d-e063-dadaa90ab31f5427-Major
68071-2758-32025-01-30C16284748780-12cef2736-7126-d83d-e063-dadaa90ab31f5427-Major
68071-2758-52025-01-30C16284748780-12cef2736-7126-d83d-e063-dadaa90ab31f5427-Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2758-2Acetaminophen20 in 1 BOTTLETABLET203
68071-2758-3Acetaminophen30 in 1 BOTTLETABLET303
68071-2758-5Acetaminophen45 in 1 BOTTLETABLET453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2758ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 3 package rows20220804_e17fa228-6db2-3e1a-e053-2995a90a705b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6730-59EA - Each0904-67308c088197-3332-449d-8a4e-f973da83c10a12018-10-11
0904-6730-60EA - Each0904-67300af87dfc-0b3e-49aa-ab5b-8f87b4fb2ed212018-12-13
0904-6730-61EA - Each0904-673036f619ef-5650-4897-beb0-7f747d55480312018-10-11
0904-6730-80EA - Each0904-67303b5af9b2-1de7-4955-ba59-3c125a3488d212018-10-11

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
68071-275868071-2758-5, 68071-2758-2, 68071-2758-3
0904-6730

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
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
ACETAMINOPHEN362O9ITL9DACTIB

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 Pharmaceuticals76cb8209-6c43-322e-e053-2991aa0a51eb2024-05-08WarningsExact identifier
ndc (product): 0904-6730
e546bbbc-8b79-421b-e053-2a95a90a40c8e17fa228-6db2-3e1a-e053-2995a90a705b2022-08-02WarningsExact identifier
spl id: e546bbbc-8b79-421b-e053-2a95a90a40c8
spl set id: e17fa228-6db2-3e1a-e053-2995a90a705b

Reported adverse events (FAERS/openFDA)#

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