Other
Drug Facts
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Childrens Mapap
FDA Label NDC 50090-2588
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Childrens Mapap (NDC 50090-2588). 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 other, active ingredient (in each 5ml), purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5Ml)
Acetaminophen 160 mg
Purpose
Pain reliever - Fever reducer
Uses
Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Temporarily reduces fever
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 product 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)
Stop Use And Ask A Doctor If
- pain gets worse or last for more than 5 days
- fever gets worse or last for 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 the reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- find right dose on chart. If possible, use weight to dose; otherwise, use age
- mL = millileter
- if needed, repeat dose every 4 hours
- do not use more than 5 doses in 24 hours
- use enclosed dosing cup only. Do not use any other device
| Weight | Age | Dose |
|---|---|---|
| under 24 lbs | Under 2 years | ask a doctor |
| 24 to 35 lbs | 2 to 3 years | 5mL |
| 36 to 47 lbs | 4 to 5 years | 7.5mL |
| 48 to 59 lbs | 6 to 8 years | 10mL |
| 60 to 71 lbs | 9 to 10 years | 12.5mL |
| 72 to 95 lbs | 11 years | 15mL |
Other Information
- each 5 mL contains: sodium 1mg
- TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.
- store at 20° - 25°C (68° - 77°F)
- this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.
Inactive Ingredients
artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol
Questions Or Comments?
Call 1-800-616-2471
How Supplied
Product: 50090-2588
NDC: 50090-2588-0 118 mL in a BOTTLE
* Please review the disclaimer below.
