EXTRA STRENGTH MAPAP PM- acetaminophen, diphenhydramine hydrochloride tablet, film coated 
Major Pharmaceuticals

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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Major Extra Strength Mapap PM Caplets

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25mg

Purposes

Pain Reliever
Nighttime Sleep Aid

Uses Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

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.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Aska doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • 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 case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical help 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 directed (see overdose warning)

​adults and children 12 years and over: Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.

children under 12 years: do not use

Other information

  • Store at room temperature

Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call (800) 616-2471

Distributed by: MAJOR® PHARMACEUTICALS

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

*This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Tylenol®.

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

See New Warnings Information adn Directions

NDC 0904-7651-51

MAJOR®

EXTRA STRENGTH

Mapap PM CAPLETS

PAIN RELIEVER ● SLEEP AID

ACETAMINOPHEN 500mg and DIPHENHYDRAMINE HCl 25mg each
*COMPARE TO active ingredients of TYLENOL® PM*
50 CAPLETS
0904-7651-51

EXTRA STRENGTH MAPAP PM 
acetaminophen, diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7651
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 68401960MK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULE (Capsule shaped Tablet) Size18mm
FlavorImprint Code GP325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7651-5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/201106/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/04/201106/30/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2019
 
Major Pharmaceuticals