Label: CHILDRENS CHEWABLE MAPAP- acetaminophen tablet, chewable
- NDC Code(s): 63187-968-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-5256
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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:
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- skin reddening
- •
- blisters
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- 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.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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.
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- chew before swallowing
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- if needed, repeat dose every 4 hours while symptoms last
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- 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
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHILDRENS CHEWABLE MAPAP
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-968(NDC:0904-5256) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) D&C RED NO. 27 (UNII: 2LRS185U6K) Product Characteristics Color pink Score no score Shape ROUND (ROUND BICONVEX TABLET) Size 10mm Flavor Imprint Code 1G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-968-30 1 in 1 CARTON 01/01/2018 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/04/2011 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-968) , RELABEL(63187-968)
