Label: CHILDRENS MAPAP- acetaminophen liquid
Contains inactivated NDC Code(s)
NDC Code(s): 76413-343-01
- Packager: Central Texas Community Health Centers
- 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 September 8, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5mL)
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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
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.
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
- 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
- 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
- Questions or Comments?
PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label
Austin/Travis Co. Health & Human Services Dept.
1000 Toyath St Austin, TX 78702 512-972-6206
TAKE ___ ML BY MOUTH ___ TIMES A DAY.
MAPAP 160 mg/5 ML #118ML NDC 76413-343-01
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-343(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 sodium (UNII: SB8ZUX40TY) 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:76413-343-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 03/01/2015 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-343) , RELABEL(76413-343)