CHILDRENS MAPAP ACETAMINOPHEN- acetaminophen liquid

Childrens MAPAP Acetaminophen by

Drug Labeling and Warnings

Childrens MAPAP Acetaminophen by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

• pain gets worse or last for more than 5 days
• fever gets worse or last for more than 3 days
• new symptoms occur
• 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

• this product does not contain directions or complete warnings for adult use
• find right dose on chart
• if possible, use weight to dose; otherwise, use age
• if needed, repeat dose every 4 hours
• 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

• Each TSP(5 mL) contains: sodium 1mg
• TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.
• store at 20° - 25°C (68° – 77°F)
• 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

INGREDIENTS AND APPEARANCE

CHILDRENS MAPAP ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-3389(NDC:0904-1985)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: FST467XS7D)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-3389-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2017

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

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-3389)