FDA.reportPublic FDA data

Childrens MAPAP

Manufacturer
Central Texas Community Health Centers
Effective date
2017-09-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:27

Label at a glance#

ProductChildrens MAPAP
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 mL = millileter if needed, repeat dose every 4 hours do not use more than 5 doses in 24 hours use enclosed dosing cup only. Do not use any other device Weight Age Dose under 24 lbs Under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 5mL 36 to 47 lbs 4 to 5 years...

Storage and handling

each 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 5mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever - Fever reducer

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

SPL UNCLASSIFIED SECTION

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

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
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

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 - WHEN USING SECTION

When using this product, do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 - 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
  • mL = millileter
  • if needed, repeat dose every 4 hours
  • do not use more than 5 doses in 24 hours
  • use enclosed dosing cup only. Do not use any other device
WeightAgeDose
under 24 lbsUnder 2 yearsask a doctor
24 to 35 lbs2 to 3 years5mL
36 to 47 lbs4 to 5 years7.5mL
48 to 59 lbs6 to 8 years10mL
60 to 71 lbs9 to 10 years12.5mL
72 to 95 lbs11 years15mL

Other information

STORAGE AND HANDLING SECTION

  • each 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, saccharin sodium, sodium benzoate, sorbitol

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-616-2471

PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Austin/Travis Co. Health & Human Services Dept.
1000 Toyath St Austin, TX 78702 512-972-6206

MAPAP
160 mg/5
ML
#118ML

Date:

Name:
Dr.

TAKE ___ ML BY MOUTH ___ TIMES A DAY.

12/2018

16M021

MAPAP 160 mg/5 ML #118ML NDC 76413-343-01

Batch: 08301709
Lot: 16M021
Exp: 12/2018
MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN1
209397Mapap Childrens 160 MG in 5 mL Oral SolutionPSN1
209397acetaminophen 32 MG/ML Oral Solution [Mapap]SBD1
307675acetaminophen 32 MG/ML Oral SolutionSCD1
307675acetaminophen 160 MG per 5 ML Oral SolutionSY1
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY1
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY1
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY1
307675APAP 32 MG/ML Oral SolutionSY1
209397APAP 32 MG/ML Oral Solution [Mapap]SY1
209397Mapap 160 mg per 5 mL Oral SolutionSY1
209397Mapap 32 MG/ML Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-343-012020-01-31C16284748780-19d75b9d0-6097-f424-e053-dadaa90a57ceChildren's Māpap ® ACETAMINOPHEN LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-343-01Childrens MAPAP118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-343CHILDRENS MAPAP (ACETAMINOPHEN) LIQUID [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 1 package rows20170909_8259aefb-88bf-4adb-8ada-8a33e1ffa26d.zip

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
76413-34376413-343-01
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
Acetaminophen362O9ITL9DACTIB
GlycerinPDC6A3C0OXIACT
Sorbitol506T60A25RIACT
Sodium BenzoateOJ245FE5EUIACT
Anhydrous citric acidXF417D3PSLIACT
FD&C Red no. 40WZB9127XOAIACT
Water059QF0KO0RIACT
saccharin sodiumSB8ZUX40TYIACT
Propylene glycol6DC9Q167V3IACT
PRUNUS SEROTINA BARK5D48E975HAIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML · Source PDF

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
6dc153b5-8e73-4c2b-b760-302f6954e7018259aefb-88bf-4adb-8ada-8a33e1ffa26d2017-09-08WarningsExact identifier
spl id: 6dc153b5-8e73-4c2b-b760-302f6954e701
spl set id: 8259aefb-88bf-4adb-8ada-8a33e1ffa26d

Reported adverse events (FAERS/openFDA)#

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