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.

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Major 44-450-children

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
sore throat
flu
toothache
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)

Dose (chewable tablets)*

 Under 24

 Under 2

Ask a doctor 

24-35

2-3

1 tablet

36-47

4-5

1 1/2 tablets

48-59 

6-8

2 tablets

60-71

9-10

2 1/2 tablets

72-95

11

3 tablets

*or as directed by a doctor

Other information

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

71205-322-24
CHILDRENS MAPAP 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-322(NDC:0904-6645)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize16mm
FlavorBUBBLE GUMImprint Code 44;450
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-322-2424 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/25/2005
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-322) , RELABEL(71205-322)

Revised: 10/2019
Document Id: ec64aad9-b16b-462b-b83c-d4b9d641e76b
Set id: 88c4183a-3032-46de-bf18-f700055f617b
Version: 2
Effective Time: 20191001
 
Proficient Rx LP