FDA Label for Childrens Chewable Mapap
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Childrens Chewable Mapap Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Other information
• Phenylketonurics: Contain Phenylalanine 14 mg per tablet• Store at room temperature in a dry place
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
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Acetaminophen 80 mg
Otc - Purpose
Purposes
Pain Reliever/Fever Reducer
Indications & Usage
Uses
• temporarily relieves minor aches and pain due to:• the common cold• flu• headache• sore throat• toothache• temporarily reduces fever.
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• skin reddening• blisters• rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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
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
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
When using this product, do not exceed recommended dose (see overdose warning)
Otc - Stop Use
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
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
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 |
Inactive Ingredient
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
Questions or comments?
Call: (800) 616-2471
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
* Please review the disclaimer below.