FDA.reportPublic FDA data

Childrens MAPAP Acetaminophen

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:52:44

Label at a glance#

ProductChildrens MAPAP Acetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache Temporarily reduces fever

Dosage and administration

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 ...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each TSP (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Fever reducer-Pain reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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
WeightAgeDose
under 24 lbsUnder 2 yearsask a doctor
24 to 35 lbs2 to 3 years1 TSP (5 mL)
36 to 47 lbs4 to 5 years1 1/2 TSP (7.5 mL)
48 to 59 lbs6 to 8 years2 TSP (10 mL)
60 to 71 lbs9 to 10 years2 1/2 TSP (12.5 mL)
72 to 95 lbs11 years3 TSP (15 mL)

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 118mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3389-42024-07-10C16284748780-1ba0f9c33-2dfc-a910-e053-dadaa90a0b85Childrens MĀPAP ® Acetaminophen Liquid
68071-3389-42023-01-30C16284748780-1ba0f9c33-2dfc-a910-e053-dadaa90a0b85Childrens MĀPAP ® Acetaminophen Liquid
68071-3389-42021-02-12C16284748780-1ba0f9c33-2dfc-a910-e053-dadaa90a0b85Childrens MĀPAP ® Acetaminophen Liquid
68071-3389-42021-01-29C16284748780-1ba0f9c33-2dfc-a910-e053-dadaa90a0b85Childrens MĀPAP ® Acetaminophen Liquid

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-1985-00ML - Milliliter0904-19853a7ef64c-8df0-4322-a91f-f54e0f3c9d3612013-02-13
0904-1985-16ML - Milliliter0904-19852906032b-7c3a-4872-b7e9-695aa95d6c1b12013-02-13
0904-1985-20ML - Milliliter0904-19853cbd29ae-733e-42cf-92cb-f21c9b56f98012013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-338968071-3389-4
0904-1985

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
SACCHARINFST467XS7DIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PRUNUS SEROTINA BARK5D48E975HAIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
D&C RED NO. 339DBA0SBB0LIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1ce94615-3278-655e-e063-6394a90abe4a549efb5c-73b1-28b8-e054-00144ff8d46c2024-07-10WarningsExact identifier
spl set id: 549efb5c-73b1-28b8-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.