Childrens Chewable Mapap

Manufacturer
Proficient Rx LP
Effective date
2019-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:03:13

Label at a glance#

ProductChildrens Chewable Mapap
Active ingredientACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

OTC - PURPOSE SECTION

Purposes

Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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

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: 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.

OTC - DO NOT USE SECTION

Do not use

  • with any other drug 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)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: In the 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • this products does not contain directions or complete warnings for adult use.
  • find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing
  • 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.

Weight

Age

Dosage

Under 24 lbs

Under 2 years

Ask a doctor

24-35 lbs

2-3 years

2 tablets

36-47 lbs

4-5 years

3 tablets

48-59 lbs

6-8 years

4 tablets

60-71 lbs

9-10 years

5 tablets

72-95 lbs

11 years

6 tablets

SPL UNCLASSIFIED SECTION

Other information

  • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
  • Store at room temperature in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

OTC - QUESTIONS SECTION

Questions or comments?

Call: (800) 616-2471

SPL UNCLASSIFIED SECTION

Distributed by:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

LIVONIA, MI 48152

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®
NDC 63187-968-30
See New Warnings Information
Children's Chewable
Mapap Acetaminophen
Fever reducer/ Pain reliever
ASPIRIN FREE ● IBUPROFEN FREE

NATURAL & ARTIFICIAL BERRY FLAVORS
30 Tablets, 80 mg EACH

AGES 2-11

63187-968-30
63187-968-30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5256-46EA - Each0904-52567c3c715c-a0f5-41d1-81f5-5e5fba03de8612012-07-24

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
63187-96863187-968-30
0904-5256

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

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
b81c018a-d775-4826-a98d-0a8ec4f5af14588d2434-f39c-4dd5-8564-0d756d7568dc2024-10-01WarningsExact identifier
spl set id: 588d2434-f39c-4dd5-8564-0d756d7568dc

Reported adverse events (FAERS/openFDA)#

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