CHILDRENS CHEWABLE MAPAP
-
acetaminophen tablet, chewable
Major Pharmaceuticals
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Drug FactsActive Ingredients (in each chewable tablet)
Acetaminophen 80 mg
Purpose
Pain Reliever/Fever Reducer
Uses
Temporarily relieves minor aches and pain due to:
■ The common cold ■ Flu ■ Headache ■ Sore throat
■ Toothache
Temporarily reduces fever.
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.
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 ■ with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
■ If your child is allergic to acetaminophen or any of the inactive ingredients in this products.
Ask a doctor before use if your child has liver disease.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
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.
Keep out of reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
Directions
■ This products does not contain directions or complete warning 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 lasts
■ 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 | TABLETS |
| 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 |
Other Information
- Phenylketonurics: Contain phenylalanine 14 mg per tablet
- Do not use if imprinted safety seal under cap is broken or missing
- Store at room temperature in a dry place
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.
Questions?
Adverse Drug Event Call:(800) 616-2471
Principal Display Panel
MAJOR
NDC 0904-5256-46
*Compare to the active ingredient in Children's Chewable Tylenol®
Children's Chewable
Mapap Acetaminophen
Fever reducer/ Pain reliever
ASPIRIN FREE ● IBUPROFEN FREE
30 Tablets, 80 mg EACH
AGES 2-6
Fruit Flavor
See New Warning Information
| CHILDRENS CHEWABLE MAPAP
acetaminophen tablet, chewable |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part343 | 05/04/2011 | |
| Labeler - Major Pharmaceuticals (191427277) |