EXTRA STRENGTH MAPAP- acetaminophen tablet 
Bryant Ranch Prepack

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mapap (Acetaminophen) Extra Strength Tablets

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain Reliever/Fever Reducer

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

Warnings

Liver warning: This product contains acetaminophen. 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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

Do not use

  • with any other drug 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 liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • 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, ask a health professional before use.

Keep out of reach of children.

Overdose warning: 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

  • 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: ask a doctor

Other information

  • Store at room temperature

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments? Call (800) 616-2471

Distributed By: MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing

HOW SUPPLIED

Product: 63629-6797

NDC: 63629-6797-1 180 TABLET in a BOTTLE

NDC: 63629-6797-2 90 TABLET in a BOTTLE

NDC: 63629-6797-3 30 TABLET in a BOTTLE

NDC: 63629-6797-4 60 TABLET in a BOTTLE

340B ACETAMINOPHEN 500MG TAB.

Label Image
EXTRA STRENGTH MAPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-6797(NDC:0904-1988)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (flat faced beveled edge) Size12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-6797-1180 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2015
2NDC:63629-6797-290 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2015
3NDC:63629-6797-330 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2015
4NDC:63629-6797-460 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/04/201111/16/2021
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-6797) , RELABEL(63629-6797)

Revised: 11/2021
Document Id: 361ebaaf-33be-405d-9dec-d2b58012cc02
Set id: f81f271c-15d5-4adb-8925-03271708a986
Version: 7
Effective Time: 20211116
 
Bryant Ranch Prepack