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NDC 63187-0588-04 Childrens MAPAP Acetaminophen 160 mg/5mL Details

Childrens MAPAP Acetaminophen 160 mg/5mL

Childrens MAPAP Acetaminophen is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 63187-0588-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	63187-0588
Product ID	63187-588_8500f34d-562e-4dec-aac9-834096181385
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Childrens MAPAP Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0588-04 (63187058804)

Pricing Information	N/A
NDC Package Code	63187-588-04
Billing NDC	63187058804
Package	118 mL in 1 BOTTLE (63187-588-04)
Marketing Start Date	2016-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 99b6d834-bba0-442f-b19d-5a211360986a Details

SPL UNCLASSIFIED SECTION

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

Weight	Age	Dose
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

INGREDIENTS AND APPEARANCE

CHILDRENS MAPAP ACETAMINOPHEN

acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-588(NDC:0904-1985)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	160 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-588-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	08/20/2012

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-588)

Revised: 11/2019

Document Id: 8500f34d-562e-4dec-aac9-834096181385

Set id: 99b6d834-bba0-442f-b19d-5a211360986a

Version: 2

Effective Time: 20191101