Childrens Mapap description, usages, side effects, indications, overdosage, supplying and lots more!

Childrens Mapap

Major Pharmaceuticals

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Major 44-452



FULL PRESCRIBING INFORMATION

Acetaminophen 80 mg

Pain reliever/fever reducer

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • flu
    • sore throat
    • toothache
  • temporarily reduces fever

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning:  If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

liver disease.

taking the blood thinning drug warfarin.

do not exceed recommended dosage.

  • pain gets worse or lasts more than 5 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.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • do not give more than directed (see overdose warning)
  • this product does not contain directions or complete warnings for adult use
  • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
 Weight (lb)  Age (yr)  Tablets
 Under 24  Under 2  Ask a doctor
 24-35  2-3  2
 36-47  4-5  3
 48-59  6-8  4
 60-71  9-10  5
 72-95  11  6
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
  • protect from light

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethelene, povidone, stearic acid, sucralose

1-800-616-2471

MAJOR®

NDC 0904-5791-46

*Compare to the active ingredient in Children's Tylenol® Meltaways®

Children's
Mapap®
Acetaminophen
Fever reducer / Pain reliever

ASPIRIN FREE • IBUPROFEN FREE

AGES 2-6

Rapid Tabs

30 Tablets, 80 mg EACH

Grape Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.
50844      REV1013F45201

Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA        M-17
Rev. 04/13
Re-order No. 006446


Major 44-452

Childrens Mapap

Acetaminophen TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5791
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
D&C RED NO. 27
D&C RED NO. 30
DEXTROSE
ETHYLCELLULOSES
FD&C BLUE NO. 1
MAGNESIUM STEARATE
mannitol
POVIDONES
STEARIC ACID
Sucralose

Product Characteristics

Color Size Imprint Code Shape
PURPLE 13 mm 44;449 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 NDC:0904-5791-46 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-12-06


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Be sure to consult your doctor before taking any medication!
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