FDA.reportPublic FDA data

Extra Strength Mapap

Manufacturer
Medsource Pharmaceuticals
Effective date
2018-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:28

Label at a glance#

ProductExtra Strength Mapap
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

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

Dosage and administration

Do not take more than the directed (see overdose warning) Adults and children 12 years and over: Take 2 tablets every 6 hours while symptoms last. Do not take more than 6 tablets in 24 hours unless directed by a doctor Do not take for more than 10 days unless directed by a doctor Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the reco...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Aspirin Free Extra Strength Pain Reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains due to:

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.

The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours.  Severe liver damage may occur if you take

  • 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

Do not use

OTC - DO NOT USE SECTION

  • 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.
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Do not take more than the directed (see overdose warning)

Adults and children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.
  • Do not take more than 6 tablets in 24 hours unless directed by a doctor
  • Do not take for more than 10 days unless directed by a doctor

Children under 12 years: Do not use adult Extra Strength product in children under 12 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

PRINCIPAL DISPLAY PANEL - 20 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
209443MAPAP Extra Strength 500 MG Oral TabletPSN1
209443acetaminophen 500 MG Oral Tablet [Mapap]SBD1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1
209443APAP 500 MG Oral Tablet [Mapap]SY1
209443Extra Strength Mapap 500 MG Oral TabletSY1
209443Mapap 500 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-656-202025-01-30C16284748780-12cef2736-b34e-d83d-e063-dadaa90ab31fDrug Facts
45865-656-302025-01-30C16284748780-12cef2736-b34e-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-656-20Extra Strength Mapap20 in 1 BOTTLE, PLASTICTABLET201
45865-656-30Extra Strength Mapap30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-656EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180728_72053f9e-cca7-7e8a-e053-2995a90a99f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-1988-59EA - Each0904-198859e9faee-e3d5-4ff9-84b0-c685998bf69412013-02-11
0904-1988-60EA - Each0904-198882c955b4-0ef5-44b8-89c9-fec81f411a3f12013-02-11
0904-1988-61EA - Each0904-1988f8dac616-228c-4c6d-a729-89cc45c9a11d12013-02-13
0904-1988-80EA - Each0904-1988e2e14895-8674-4abc-b0dc-0a23d8e44d3212013-02-11

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-65645865-656-20, 45865-656-30
0904-1988

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
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
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
72053f9e-cca8-7e8a-e053-2995a90a99f072053f9e-cca7-7e8a-e053-2995a90a99f02018-07-27WarningsExact identifier
spl id: 72053f9e-cca8-7e8a-e053-2995a90a99f0
spl set id: 72053f9e-cca7-7e8a-e053-2995a90a99f0

Reported adverse events (FAERS/openFDA)#

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