Acetaminophen Tablets

Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:28

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 8 tablets in 24 hours do not take for more than 10 days unless directed by a doctor do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen Tablets, 325mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to:
    1. headache
    2. muscular aches
    3. the common cold
    4. minor pain of arthritis
    5. backache
    6. toothache
    7. premenstrual and menstrual cramps

WARNINGS

WARNINGS SECTION

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

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

have liver disease

Ask a doctor or pharmacist 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
  • 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.

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: Taking more than the recommended dose (overdose) may cause liver damage. 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

SPL UNCLASSIFIED SECTION

adults and children

12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch, stearic acid

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

325 mg Tablets
325 mg Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN1
313782acetaminophen 325 MG Oral TabletSCD1
313782APAP 325 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-024-302019-10-21C16284748780-1956f9ecf-cbca-621f-e053-dbdaa90a74adAcetaminophen Tablets
67046-024-602019-10-21C16284748780-1956f9ecf-cbca-621f-e053-dbdaa90a74adAcetaminophen Tablets
67046-024-622019-10-21C16284748780-1956f9ecf-cbca-621f-e053-dbdaa90a74adAcetaminophen Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-024-30Acetaminophen30 in 1 BLISTER PACKTABLET301
67046-024-60Acetaminophen60 in 1 BLISTER PACKTABLET601
67046-024-62Acetaminophen60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-024ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 3 package rows20100806_6a175aa5-62de-4096-be2d-b0bf66f5e82a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-1982-51EA - Each0904-1982d1f0fa3d-d768-4a49-a185-2ac685e3c89012013-02-11
0904-1982-59EA - Each0904-1982a24472eb-cf1e-4286-a017-9b42d265de7312013-02-11
0904-1982-60EA - Each0904-1982cf37093b-6a2f-46ec-ace3-b8236093ba0f12013-02-11
0904-1982-61EA - Each0904-1982402a4b9b-2be1-45c4-a1d9-316f155ac90812012-07-24
0904-1982-80EA - Each0904-1982ea47e96c-011a-4315-be09-7f12254d47fa12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67046-02467046-024-30, 67046-024-60, 67046-024-62
0904-1982

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6a175aa5-62de-4096-be2d-b0bf66f5e82a6a175aa5-62de-4096-be2d-b0bf66f5e82a2010-07-30WarningsExact identifier
spl id: 6a175aa5-62de-4096-be2d-b0bf66f5e82a
spl set id: 6a175aa5-62de-4096-be2d-b0bf66f5e82a

Reported adverse events (FAERS/openFDA)#

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