Acetaminophen Regular Strength

Manufacturer
Magno-Humphries, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:14

Label at a glance#

ProductAcetaminophen Regular Strength
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains associated with: headache muscular aches  backache arthritis common cold toothache menstrual cramps temporarily reduces fever

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 as needed do not take more than 8 tablets in 24 hours do not take for more than 10 days unless directed by a doctor children 6-11 years take 1 tablets every 4 to 6 hours as needed do not take more than 4 tablets in 24 hours do not take for more than 5 days unless directed by a doctor childr...

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains associated with:
  • headache
  • muscular aches 
  • backache
  • arthritis
  • common cold
  • toothache
  • menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 8 caplets 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 drugs 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days. 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. 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 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablets every 4 to 6 hours as needed
  • do not take more than 4 tablets in 24 hours
  • do not take for more than 5 days unless directed by a doctor
children under 6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature. Protect from moisture. 
  • avoid excessive heat 40ºC (above 104º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn starch, pregelatinized starch, stearic acid, may contain povidone, sodium starch glycolate

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN4
313782acetaminophen 325 MG Oral TabletSCD4
313782APAP 325 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-720-02Acetaminophen Regular Strength100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-720ACETAMINOPHEN REGULAR STRENGTH (ACETAMINOPHEN) TABLET [MAGNO-HUMPHRIES, INC.]4Current NDC, Legacy NDC, 1 package rows20231030_9d22d642-8aaf-d17e-e053-2995a90ae182.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54257-72054257-720-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
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
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
ndc (package): 54257-720-02
ndc (product): 54257-720
ndc11 (package): 54257072002
spl id: 08bf78b4-64d4-cd41-e063-6294a90a96db
spl set id: 9d22d642-8aaf-d17e-e053-2995a90ae182

Reported adverse events (FAERS/openFDA)#

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