Label: CHILDRENS MAPAP ACETAMINOPHEN- acetaminophen liquid
- NDC Code(s): 68071-3389-4
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-1985
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 12, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TSP (5 mL))
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
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.
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.
- 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)
- Each TSP(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
- PRINCIPAL DISPLAY PANEL - 118mL Bottle Carton
INGREDIENTS AND APPEARANCE
CHILDRENS MAPAP ACETAMINOPHEN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3389(NDC:0904-1985) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) SACCHARIN (UNII: FST467XS7D) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3389-4 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/20/2012 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-3389)