CHILDRENS CHEWABLE MAPAP- acetaminophen tablet, chewable
Proficient Rx LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Major Children's Chewable Mapap

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purposes

Pain Reliever/Fever Reducer

Uses

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

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

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 a doctor before use if your child has liver disease.

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

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

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.

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.

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

Other information

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

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 or comments?

Call: (800) 616-2471

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

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

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)

Revised: 11/2019
Document Id: f2d98e1e-740a-4411-af91-1f5e9b4766ea
Set id: 588d2434-f39c-4dd5-8564-0d756d7568dc
Version: 2
Effective Time: 20191101
Proficient Rx LP