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

Extra Strength Mapap PM by

Drug Labeling and Warnings

Extra Strength Mapap PM by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25mg

PURPOSE

Purposes

Pain Reliever
Nighttime Sleep Aid

INDICATIONS & USAGE

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

WARNINGS

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

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 DOCTOR

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

ASK DOCTOR/PHARMACIST

Aska doctor or pharmacist before use if you are

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

WHEN USING

When using this product

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS AND PRECAUTIONS

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• Store at room temperature

INACTIVE INGREDIENT

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

Questions or comments?

Call (800) 616-2471

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MAPAP PM 
acetaminophen, diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7651
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	CAPSULE (Capsule shaped Tablet)	Size	18mm
Flavor		Imprint Code	GP325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7651-51	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2011	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/04/2011	06/30/2020

Labeler - Major Pharmaceuticals (191427277)