FDA.reportPublic FDA data

Pain Reliever

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 23:58:13

Label at a glance#

ProductPain Reliever
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

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

Dosage and administration

(see overdose warning) do not take more than directed take 2 caplets every 6 hours while symptoms last; do not take more than 6 caplets in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor adults and children 12 years and over: ask a doctor children under 12 years:

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

acetaminophen may cause severe skin reactions. Allergy alert:

Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • 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
  • skin reddening
  • blisters
  • rash

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

  • 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

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 children even if you do not notice any signs or symptoms. Overdose warning:

Directions

DOSAGE & ADMINISTRATION SECTION

  • (see overdose warning) do not take more than directed
  • take 2 caplets every 6 hours while symptoms last; do not take more than 6 caplets in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor adults and children 12 years and over:
  • ask a doctor children under 12 years:

Other information

SPL UNCLASSIFIED SECTION

  • store between 20º to 25ºC (68º to 77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxypropyl methyl cellulose, pregelatinized starch, povidone k-30, polyethylene glycol, stearic acid, sodium starch glycolate.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN4
198440acetaminophen 500 MG Oral TabletSCD4
198440APAP 500 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-473-02Pain Reliever100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-473PAIN RELIEVER (ACETAMINOPHEN) TABLET [MAGNO-HUMPHRIES, INC.]4Current NDC, Legacy NDC, 1 package rows20231030_9d22bedb-9fb3-8421-e053-2a95a90acf4a.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
54257-47354257-473-02

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
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
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
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
ndc (package): 54257-473-02
ndc (product): 54257-473
ndc11 (package): 54257047302
spl id: 08bf6b23-2a85-3732-e063-6294a90a2305
spl set id: 9d22bedb-9fb3-8421-e053-2a95a90acf4a

Reported adverse events (FAERS/openFDA)#

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