FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:50

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily reduces fever and relieves minor aches and pains caused by common cold headache toothache backache muscular aches minor pain of arthritis premenstrual and menstrual cramps

Dosage and administration

adults and children 12 years and over 2 tablets every 4 to 6 hours while symptoms last, not more than 10 tablets in 24 hours. Do not use more than 10 days unless directed by doctor children 6 to 11 years 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours. Do not use more than 5 days unless directed by doctor children under 6 years ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever / Fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily reduces fever and relieves minor aches and pains caused by

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

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 tablets 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

do not use with any other drug containing acetaminophen (prescription or non prescription).        If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • adult’s pain gets worse or lasts more than 10 days
  • child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning:Taking more than the recommended dose may cause liver damage. In case of overdose contact Poisom Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs of symptoms.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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

adults and children 12 years and over2 tablets every 4 to 6 hours while symptoms last, not more than 10 tablets in 24 hours. Do not use more than 10 days unless directed by doctor
children 6 to 11 years1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours. Do not use more than 5 days unless directed by doctor
children under 6 yearsask a doctor

Other Information

SPL UNCLASSIFIED SECTION

store at 15-30 °C (59-86 °F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or Comments

OTC - QUESTIONS SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC- 54738-548-01... 100 APAP 325MG TABS

IMG_4680IMG_4680

NDC- 54738-548-03... 1000 APAP 325MG TABS

NDC- 54738-548-50... 50 APAP 325MG TABS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN2
313782acetaminophen 325 MG Oral TabletSCD2
313782APAP 325 MG Oral TabletSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054738548013GTIN-13: 0054738548013
EAN-13: 0054738548013
GTIN-12: 054738548013
UPC-A: 054738548013
GTIN storage (14 digits): 00054738548013		IMG_4680.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-548-01Acetaminophen100 in 1 BOTTLETABLET1002
54738-548-03Acetaminophen1000 in 1 BOTTLETABLET10002
54738-548-50Acetaminophen50 in 1 BOTTLETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-548ACETAMINOPHEN TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20171030_cda8e158-01ac-4c08-826e-4a0c7278e805.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-548-01EA - Each54738-548984aae7b-5661-4036-a82a-b6011769141612017-11-06
54738-548-03EA - Each54738-548fe37789b-7d64-4080-b66e-9cb7d6407e3a12017-11-06
54738-548-50EA - Each54738-5482319074e-d642-4008-b9ac-7d58b14180e612017-11-06

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
54738-54854738-548-01, 54738-548-03, 54738-548-50

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
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
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
AcetaminophenACETAMINOPHENRichmond Pharmaceuticals, Inc.cda8e158-01ac-4c08-826e-4a0c7278e8052017-10-30WarningsExact identifier
ndc (package): 54738-548-50
ndc (package): 54738-548-01
ndc (package): 54738-548-03
ndc (product): 54738-548
ndc11 (package): 54738054803
ndc11 (package): 54738054801
ndc11 (package): 54738054850
spl id: 5cc3aaa6-e192-a116-e053-2991aa0a1422
spl set id: cda8e158-01ac-4c08-826e-4a0c7278e805

Reported adverse events (FAERS/openFDA)#

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