Active Ingredient (In Each Tsp (5 Ml))
Acetaminophen 160 mg
Childrens Mapap Acetaminophen
FDA Label NDC 17856-1986
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Childrens Mapap Acetaminophen (NDC 17856-1986). 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 tsp (5 ml)), purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Fever reducer-Pain reliever
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
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 - Stop Use
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 - Pregnancy Or Breast Feeding
ask a health professional before use If pregnant or breast-feeding,
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
- if needed, repeat dose every 4 hours
- do not use more than 5 doses in 24 hours
| Weight | Age | Dose |
|---|---|---|
| under 24 lbs | Under 2 years | ask a doctor |
| 24 to 35 lbs | 2 to 3 years | 1 TSP (5 mL) |
| 36 to 47 lbs | 4 to 5 years | 1 1/2 TSP (7.5 mL) |
| 48 to 59 lbs | 6 to 8 years | 2 TSP (10 mL) |
| 60 to 71 lbs | 9 to 10 years | 2 1/2 TSP (12.5 mL) |
| 72 to 95 lbs | 11 years | 3 TSP (15 mL) |
Other Information
- sodium 1mg Each TSP(5 mL) contains:
- 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, sodium benzoate, sodium saccharin,sorbitol
Questions?
To Report Adverse Drug Event call 1-800-616-2471 Weekdays, 9AM - 5PM Eastern Time
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