Major Children's Chewable Mapap
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
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.
- •more than 5 doses in 24 hours, which is the maximum daily amount
- •with other drugs containing acetaminophen
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
These could be signs of a serious condition.
- •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
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
| 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 |
- •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.
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 InformationChildren's Chewable Mapap Acetaminophen Fever reducer/ Pain reliever ASPIRIN FREE ● IBUPROFEN FREE
NATURAL & ARTIFICIAL BERRY FLAVORS30 Tablets, 80 mg EACH
AGES 2-11