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

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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 2 caplets in 24 hours,which is the maximum daily amount for this product
  
• with other drugs containing acetaminophen 
• 3 or more alcoholic drinks every day while using this product
  

Do not use

• 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.
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• 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
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostrate gland
• glaucoma
  

Ask a 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 serious underlying medical illness.
  
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• any new symptoms appear
• 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: 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

Do not take more than directed (See overdose warning)

Adults and children 12 years and over:

• take 2 caplets at bedtime if needed, or as directed by a doctor

Children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

• Store at room temperature
  

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 and Titanium Dioxide.

Questions?

Adverse Drug Event call (800) 616-2471

Principal Display Panel Extra Strength Mapap PM Caplets

NDC 0904-7651-51

See New Warning Information

Major®

Extra Strength
Mapap PM
CAPLETS

PAIN RELIEVER
SLEEP AID
ACETAMINOPHEN
DIPHENHYDRAMINE HCl

COMPARE TO active ingredients of Tylenol ® PM

50 CAPLETS

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

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   CROSPOVIDONE   FD&C BLUE NO. 1   HYDROXYPROPYL CELLULOSE   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POVIDONE   STARCH, CORN   PROPYLENE GLYCOL   SILICON DIOXIDE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   TITANIUM DIOXIDE

Product Characteristics Color blue Score no score Shape CAPSULE (Capsule shaped Tablet) Size 18mm Flavor Imprint Code GP325 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0904-7651-51 50 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	05/04/2011

Labeler - Major Pharmaceuticals (191427277)

Revised: 05/2011Major Pharmaceuticals