FDA.reportPublic FDA data

ACETAMINOPHEN TABLET 325MG

Manufacturer
Apotheca, Inc
Effective date
2013-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:11

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure7 sections

Indications and uses

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

Label contents#

Full prescribing information#

DRUG FACTS: ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

USES

OTC - PURPOSE SECTION

Temporarily relieves minor aches and pains due to

  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • menstrual cramps

Temporarily reduces fever

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

do not take more then directed

adults and children 12 years and over

take 1 to 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

children 6 to under 12 years

take 1 tablet every 4 to 6 hours as needed. Do not take nore than 5 tablets in 24 hours

children under 6 years

consult a doctor. Do not use this adult regular strength product in children under 6 years of age, this will provide more than the recommended dose (overdose) acetominophen and may cause liver damage.

Tamper Evident: do not use if imprinted safety seal under cap is broken or missingStore between 20-25oC (68-77oF)Use by expiration date on packageTo report adverse drug events call 1-800-332-1088

WARNINGS

WARNINGS SECTION

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

  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product

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

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • Pain gets worse or lasts more than 10 days in adults and children
  • 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 sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

 Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

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

 

Adults and children 12 years and over                     

Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours.

Children 6 to under 12 years

Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours.

Children under 6 years

Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • use by expiration date on package

 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 12634-111-74

Acetaminophen

NON-ASPIRIN

Pain & Fever

Reliever

RejuviLife

24 TABLETS 325 MG

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca, Inc

image descriptionimage description

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
12634-111-012020-01-31C16284748780-19d75b9d0-0043-f424-e053-dadaa90a57ceACETAMINOPHEN TABLET 325MG
12634-111-102020-01-31C16284748780-19d75b9d0-0043-f424-e053-dadaa90a57ceACETAMINOPHEN TABLET 325MG
12634-111-602020-01-31C16284748780-19d75b9d0-0043-f424-e053-dadaa90a57ceACETAMINOPHEN TABLET 325MG
12634-111-742020-01-31C16284748780-19d75b9d0-0043-f424-e053-dadaa90a57ceACETAMINOPHEN TABLET 325MG
12634-111-912020-01-31C16284748780-19d75b9d0-0043-f424-e053-dadaa90a57ceACETAMINOPHEN TABLET 325MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-111-01Acetaminophen100 in 1 BOTTLETABLET1001
12634-111-10Acetaminophen1000 in 1 BOTTLETABLET10001
12634-111-60Acetaminophen60 in 1 BOTTLETABLET601
12634-111-74Acetaminophen24 in 1 BOTTLETABLET241
12634-111-91Acetaminophen1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-111ACETAMINOPHEN TABLET [APOTHECA, INC]1Legacy NDC, 5 package rows20131012_b8e87809-405f-4e2a-9b42-3ca10c38da13.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-353-07EA - Each16103-353be19f1cb-5a83-4ab8-a81c-dbc7b6c366b312013-05-02
16103-353-08EA - Each16103-353d0efd342-8f78-4b8b-b2ab-963c13f461bf12013-05-02
16103-353-11EA - Each16103-353239e09b4-a5bc-4312-a3cc-d82250536ba312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3T1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

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
12634-11112634-111-74, 12634-111-60, 12634-111-01, 12634-111-10, 12634-111-91
16103-353

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
POVIDONESFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
STARCH, POTATO8I089SAH3TIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET / ORAL458 mgExact identifier — unii+route+dosage form

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
Pharbetol Regular strengthACETAMINOPHENPharbest Pharmaceuticals, Inc.e0a39957-d918-4125-88f9-0e550b976fa12025-12-24WarningsExact identifier
ndc (product): 16103-353
131d4041-7086-411f-ab71-37c091d1377ab8e87809-405f-4e2a-9b42-3ca10c38da132013-07-29WarningsExact identifier
spl id: 131d4041-7086-411f-ab71-37c091d1377a
spl set id: b8e87809-405f-4e2a-9b42-3ca10c38da13

Reported adverse events (FAERS/openFDA)#

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