Major Pharmaceuticals Infants' Mapap® Concentrated Drops Drug Facts

Manufacturer
Rebel Distributors Corp
Effective date
2012-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:31

Label at a glance#

Productmapap infants concentrated
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dropper designed for use with this product. Do not use any other dosing device. fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not give more than 5 time...

Storage and handling

store at 20°-25°C (68°-77°F) do not use if printed bottle wrap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each 0.8 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 80 mg

Purpose

OTC - PURPOSE SECTION

Fever reducer/pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

with any other drug 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dropper designed for use with this product. Do not use any other dosing device.
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • replace dropper tightly to maintain child resistance
  • this product does not contain directions or complete warnings for adult use
Dosing Chart
Weight(lb) Age(yr)Dose (mL)
under 24under 2 years ask a doctor
24-352–3 years 1.6 mL (0.8 + 0.8 mL)

Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)
  • do not use if printed bottle wrap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mapap 80mg/0.8ml
Mapap 80mg/0.8ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
243675acetaminophen 80 MG in 0.8 mL Oral SuspensionPSN1
1048963acetaminophen 100 MG/ML Oral Suspension [Mapap]SBD1
243675acetaminophen 100 MG/ML Oral SuspensionSCD1
243675acetaminophen 160 MG per 1.6 ML Oral SuspensionSY1
243675acetaminophen 80 MG per 0.8 ML Oral SuspensionSY1
243675APAP 100 MG/ML Oral SuspensionSY1
1048963APAP 100 MG/ML Oral Suspension [Mapap]SY1
1048963Mapap 100 MG/ML Oral SuspensionSY1
1048963Mapap 80 MG per 0.8 ML Oral SuspensionSY1
1048963Mapap Infants' Concentrated Drops 10 % Oral SuspensionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-267-152019-09-24C16284748780-1934fe258-4c2f-48b1-e053-8cdaa90a720aMajor Pharmaceuticals Infants' Mapap® Concentrated Drops Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-267-15mapapinfants concentrated15 mL in 1 BOTTLESUSPENSION/ DROPS151
21695-267-15mapapinfants concentrated1 in 1 CARTONSUSPENSION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-267MAPAP INFANTS CONCENTRATED (ACETAMINOPHEN) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]12 package rows20120426_1df75cdf-dc04-41f8-846e-77ce9ab24548.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-267-15ML - Milliliter21695-26705e20c01-3d8e-4187-a89b-0ed6e3e13ad712012-07-24
0904-5255-30ML - Milliliter0904-5255813d568a-4546-4350-889c-aa9cf1a07ec412012-07-24
0904-5255-35ML - Milliliter0904-5255f7327d50-2059-4dcb-8f60-42fb30200bbc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-26721695-267-15
0904-5255

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 425 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii candidate
61 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRASYNOVIAL0.1 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM / BUCCAL9 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJPOWDER, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
10 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / INTRAMUSCULAR0.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates

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
1df75cdf-dc04-41f8-846e-77ce9ab245481df75cdf-dc04-41f8-846e-77ce9ab245482012-01-17WarningsExact identifier
spl id: 1df75cdf-dc04-41f8-846e-77ce9ab24548
spl set id: 1df75cdf-dc04-41f8-846e-77ce9ab24548

Reported adverse events (FAERS/openFDA)#

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