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:
Proficient Rx LP
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer
Authorization status:
OTC monograph not final
Authorization number:
71205-322-24

CHILDRENS 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.

----------

Major 44-450-children

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

temporarily relieves minor aches and pains due to:

headache

sore throat

toothache

the common cold

temporarily reduces fever

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

skin reddening

blisters

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

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

Weight (lb)

Age (yr)

Dose (chewable tablets)*

Under 24

Under 2

Ask a doctor

24-35

1 tablet

36-47

1 1/2 tablets

48-59

2 tablets

60-71

9-10

2 1/2 tablets

72-95

3 tablets

*or as directed by a doctor

Other information

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

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

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

Inactive ingredients

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

hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR

NDC 71205-322-24

Children's

Māpap®

ACETAMINOPHEN

160 mg Chewable Tablets

Pain reliever / Fever reducer

ASPIRIN FREE IBUPROFEN FREE

AGES

2-11

Chew or crush tablets completely before swallowing.

24 Chewable Tablets,

160 mg EACH

Bubble Gum Flavor

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA M-17

Relabeled by PROFICIENT RX LP

Thousand Oaks, CA 91320

Rev. 11/18

Re-order No. 700846

50844 REV1018B45008

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

®

CHILDRENS MAPAP

acetaminophen tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7120 5-322(NDC:0 9 0 4-6 6 45)

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

16 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

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

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

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)

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

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

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

Product Characteristics

Color

PINK

S core

2 pieces

Proficient Rx LP

S hap e

ROUND

S iz e

16 mm

Flavor

BUBBLE GUM

Imprint Code

44;450

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7120 5-322-24

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 2/25/20 0 5

Labeler -

Proficient Rx LP (079196022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro ficient Rx LP

0 79 19 6 0 22

REPACK(7120 5-322) , RELABEL(7120 5-322)

Revised: 10/2019

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