Childrens Chewable Mapap
FDA Label NDC 68151-2262

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Childrens Chewable Mapap (NDC 68151-2262). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each chewable tablet), purposes, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.





WeightAgeTablets
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.