Mapap

Manufacturer
St. Mary's Medical Park Pharmacy | GEMINI PHARMACEUTICALS INC.
Effective date
2018-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:48:23

Label at a glance#

ProductMapap
Active ingredientACETAMINOPHEN
Label structure9 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 directed    AGE    DOSE    Adults and children 12 years and over    Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours    Children 6 to 11 years    Take 1 tablet every 4 to 6 hours 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 children under 6 years of age...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Aspirin-Free Pain Reliever/ Fever Reducer

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. 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

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 the user has

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if the user is

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 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 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.

Overdose warning:

OVERDOSAGE SECTION

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. (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 directed

   AGE

   DOSE

   Adults and children 12 years and over

  

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

   Children 6 to 11 years

  

  • Take 1 tablet every 4 to 6 hours 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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions or comments?

OTC - QUESTIONS SECTION

Adverse Drug Event call (800) 616-2471

Tamper Evident:  Do not use if sealed blister units are broken or damaged.

LHC54731216

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

acetacet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-935-50EA - Each60760-935b392dae0-451a-4cc5-bced-549f8e652ac612017-12-14
0904-1982-51EA - Each0904-1982d1f0fa3d-d768-4a49-a185-2ac685e3c89012013-02-11
0904-1982-59EA - Each0904-1982a24472eb-cf1e-4286-a017-9b42d265de7312013-02-11
0904-1982-60EA - Each0904-1982cf37093b-6a2f-46ec-ace3-b8236093ba0f12013-02-11
0904-1982-61EA - Each0904-1982402a4b9b-2be1-45c4-a1d9-316f155ac90812012-07-24
0904-1982-80EA - Each0904-1982ea47e96c-011a-4315-be09-7f12254d47fa12013-02-11

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
60760-93560760-935-50
0904-1982

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
d2436471-fa6d-40b2-e053-2a95a90aa3dd5e98432a-652b-bab8-e053-2a91aa0afaa82021-12-03WarningsExact identifier
spl set id: 5e98432a-652b-bab8-e053-2a91aa0afaa8

Reported adverse events (FAERS/openFDA)#

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