CHILDRENS MAPAP- acetaminophen tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache toothache sore throat the common cold flu - headache - toothache - sore throat - the common cold - flu - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
0904-5791-46

CHILDRENS MAPAP- acetaminophen tablet, chewable

Major Pharmaceuticals

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.

----------

Major 44-452

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache

toothache

sore throat

the common cold

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 dosage.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222)

right away. Prompt medical attention is critical for adults as well as for children even if you do not

notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use

do not give more than directed

find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

chew or crush tablets completely before swallowing; do not swallow tablets whole

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)

Dos e

(chewable tablets)*

Under 24

Under 2

Ask a doctor

24-35

2 tablets

36-47

3 tablets

48-59

4 tablets

60-71

9-10

5 tablets

72-95

6 tablets

*or as directed by a doctor

Other information

avoid high humidity

store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

see end flap for expiration date and lot number

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates

hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol,

polyethylene, stearic acid, sucralose

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-5791-46

Children's

Māpap®

ACETAMINOPHEN

80 mg Chewable Tablets

Pain reliever / Fever reducer

ASPIRIN FREE IBUPROFEN FREE

AGES 2-6

30 Chewable Tablets

Chew or crush

tablets completely

before swallowing.

Grape Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0119H45201

Distributed by MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA M-17 Rev. 02/19

Re-order No. 006446

Major 4 4 -4 52

CHILDRENS MAPAP

acetaminophen tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-579 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

8 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

D&C RED NO . 2 7 ALUMINUM LAKE (UNII: ZK6 4F7XSTX)

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

CRO SPO VIDO NE, UNSPECIFIED (UNII: 2S78 30 E56 1)

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

Product Characteristics

Color

PURPLE

S core

no sco re

S hap e

ROUND

S iz e

13mm

Flavor

GRAPE

Imprint Code

44;452

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-579 1-

1 in 1 CARTON

12/0 6 /20 0 4

1

30 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

12/0 6 /20 0 4

Labeler -

Major Pharmaceuticals (191427277)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(0 9 0 4-579 1)

Establishment

Major Pharmaceuticals

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 9 0 4-579 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 9 0 4-579 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(0 9 0 4-579 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(0 9 0 4-579 1)

Revised: 4/2020

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