CHILDRENS CHEWABLE MAPAP- acetaminophen tablet, chewable

Childrens Chewable Mapap by

Drug Labeling and Warnings

Childrens Chewable Mapap by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

PURPOSE

Purposes

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

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

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.

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.

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.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product

ASK DOCTOR

Ask a doctor before use if your child has liver disease.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

WHEN USING

When using this product, do not exceed recommended dose (see overdose warning)

STOP USE

Stop use and ask a doctor if

• 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• this products does not contain directions or complete warnings for adult use.
• find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
• chew before swallowing
• if needed, 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	Age	Dosage
Under 24 lbs	Under 2 years	Ask a doctor
24-35 lbs	2-3 years	2 tablets
36-47 lbs	4-5 years	3 tablets
48-59 lbs	6-8 years	4 tablets
60-71 lbs	9-10 years	5 tablets
72-95 lbs	11 years	6 tablets

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Other information

• Phenylketonurics: Contain Phenylalanine 14 mg per tablet
• Store at room temperature in a dry place

INACTIVE INGREDIENT

Inactive ingredients Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

QUESTIONS

Questions or comments?

Call: (800) 616-2471

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Distributed by:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

LIVONIA, MI 48152

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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

PRINCIPAL DISPLAY PANEL

MAJOR®
NDC: 63187-968-30
See New Warnings Information
Children's Chewable
Mapap Acetaminophen
Fever reducer/ Pain reliever
ASPIRIN FREE ● IBUPROFEN FREE

NATURAL & ARTIFICIAL BERRY FLAVORS
30 Tablets, 80 mg EACH

AGES 2-11

INGREDIENTS AND APPEARANCE

CHILDRENS CHEWABLE MAPAP 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-968(NDC:0904-5256)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND (ROUND BICONVEX TABLET)	Size	10mm
Flavor		Imprint Code	1G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-968-30	1 in 1 CARTON	01/01/2018
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(63187-968) , RELABEL(63187-968)