Extra Strength Mapap PM description, usages, side effects, indications, overdosage, supplying and lots more!

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Extra Strength Mapap PM

Major Pharmaceuticals
Gemini Pharmaceuticals, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25mg

Purposes

Pain reliever
Nighttime Sleep Aid

Extra Strength Mapap PM 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
  • new symptoms occur
  • redness or swelling is present

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 of age and over:

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

Children under 12 years of age: 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.

Extra Strength Mapap PM Other information

  • Store at room temperature
  • Do not use if imprinted safety seal under cap is broken or missing.

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 and Titanium Dioxide.

Questions?

Adverse Drug Event call (800) 616-2471

Principal Display Panel Extra Strength Mapap PM Caplets


See New Warnings Information



Mapap PM










Extra Strength Mapap PM

Extra Strength Mapap PM

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-7651
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 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 Size Imprint Code Shape
blue 18 mm GP325 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-7651-51 50 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-05-04


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Be sure to consult your doctor before taking any medication!
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