CHILDRENS MAPAP ACETAMINOPHEN- acetaminophen liquid 
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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Childrens MĀPAP® Acetaminophen Liquid

Drug Facts

Active ingredient
(in each TSP (5 mL))

Acetaminophen 160 mg

Purpose

Fever reducer-Pain reliever

Uses

Temporarily relieves minor aches and pains 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

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

1.
with any other product 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.

Stop use and ask a doctor if

1.
pain gets worse or last for more than 5 days
2.
fever gets worse or last for more than 3 days
3.
new symptoms occur
4.
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use

Keep out of the reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

1.
this product does not contain directions or complete warnings for adult use
2.
find right dose on chart
3.
if possible, use weight to dose; otherwise, use age
4.
if needed, repeat dose every 4 hours
5.
do not use more than 5 doses in 24 hours
WeightAgeDose

under 24 lbs

Under 2 years

ask a doctor

24 to 35 lbs

2 to 3 years

1 TSP (5 mL)

36 to 47 lbs

4 to 5 years

1 1/2 TSP (7.5 mL)

48 to 59 lbs

6 to 8 years

2 TSP (10 mL)

60 to 71 lbs

9 to 10 years

2 1/2 TSP (12.5 mL)

72 to 95 lbs

11 years

3 TSP (15 mL)

Other information

1.
Each TSP(5 mL) contains: sodium 1mg
2.
TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.
3.
store at 20° - 25°C (68° – 77°F)
4.
this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Inactive ingredients

artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sodium saccharin,sorbitol

Questions?

To Report Adverse Drug Event call 1-800-616-2471 Weekdays, 9AM - 5PM Eastern Time

PRINCIPAL DISPLAY PANEL - 118mL Bottle Carton

NDC 63187-588-04
TAMPER EVIDENT

MAJOR®

Children's
FEVER REDUCER-PAIN RELIEVER
Māpap®
ACETAMINOPHEN LIQUID

Fast, Effective Relief
of Children's
Fever and Pain

1.
Alcohol Free
2.
Aspirin Free
3.
Cherry Flavor

See New Warnings Information

COMPARE TO the active
ingredient of TYLENOL®* LIQUID

4 Fl. OZ. (118mL)
80 mg per 1/2 teaspoonful (160 mg per 5 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

63187-588-04
CHILDRENS MAPAP ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-588(NDC:0904-1985)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Anhydrous citric acid (UNII: XF417D3PSL)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
Water (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Propylene glycol (UNII: 6DC9Q167V3)  
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-588-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/20/2012
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(63187-588)

Revised: 11/2019
Document Id: 8500f34d-562e-4dec-aac9-834096181385
Set id: 99b6d834-bba0-442f-b19d-5a211360986a
Version: 2
Effective Time: 20191101
 
Proficient Rx LP