Childrens MAPAP Acetaminophen

Manufacturer
Proficient Rx LP
Effective date
2019-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:58:00

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

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...

Storage and handling

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.

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

  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

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

  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.

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

  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
WeightAgeDose

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

STORAGE AND HANDLING SECTION

  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

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

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

63187-588-04
63187-588-04

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
63187-58863187-588-04
0904-1985

Ingredients#

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

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

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
2e220fd3-3ae2-4193-a57e-3990229ff31599b6d834-bba0-442f-b19d-5a211360986a2024-10-01WarningsExact identifier
spl set id: 99b6d834-bba0-442f-b19d-5a211360986a

Reported adverse events (FAERS/openFDA)#

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