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#
Contacts and useful links#
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5256-46 | EA - Each | 0904-5256 | 7c3c715c-a0f5-41d1-81f5-5e5fba03de86 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Childrens Chewable Mapap
- Acetaminophen
- ASPARTAME
- SILICON DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MANNITOL
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- SODIUM CHLORIDE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- SORBITOL
- STEARIC ACID
- SUCRALOSE
- D&C RED NO. 27
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63187-968 | 63187-968-30 |
| 0904-5256 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| SORBITOL | 506T60A25R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b81c018a-d775-4826-a98d-0a8ec4f5af14 | 588d2434-f39c-4dd5-8564-0d756d7568dc | 2024-10-01 | Warnings | 588d2434-f39c-4dd5-8564-0d756d7568dc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
