FDA Label for Childrens Chewable Mapap
View Indications, Usage & Precautions
Childrens Chewable Mapap Product Label
The following document was submitted to the FDA by the labeler of this product Carilion Materials Management. 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.
Active Ingredient (In Each Chewable Tablet)
Acetaminophen 80 mg
Purposes
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
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. Liver 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. Sore throat warning:
Otc - 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 pharmacist. ■ if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Do not use
Otc - Ask Doctor
liver disease.
Ask a doctor before use if your child has
Otc - Ask Doctor/Pharmacist
taking the blood thinning drug warfarin.
Ask a doctor or pharmacist before use if your child is
Otc - When Using
When using this product: Do not exceed recommended dose.
Otc - Stop Use
■ 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 Stop use and ask a doctor if
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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. Overdose warning:
Directions
■ ■ 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.
This products does not contain directions or complete warnings for adult use.
| 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.
* Please review the disclaimer below.