Label: MAPAP INFANTS CONCENTRATED- acetaminophen suspension/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-267-15 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0904-5255
- 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.
Drug Label Information
Updated January 17, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 0.8 mL)
- Purpose
- Uses
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Warnings
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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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Directions
- do not give more than directed (see Liver warning)
- shake well before using
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- use only enclosed dropper designed for use with this product. Do not use any other dosing device.
- fill to dose level
- dispense liquid slowly into child’s mouth, toward inner cheek
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- replace dropper tightly to maintain child resistance
- this product does not contain directions or complete warnings for adult use
Dosing Chart Weight(lb) Age(yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1.6 mL (0.8 + 0.8 mL) Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MAPAP INFANTS CONCENTRATED
acetaminophen suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-267(NDC:0904-5255) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg in 0.8 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARRAGEENAN (UNII: 5C69YCD2YJ) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED (opaque) Score Shape Size Flavor CHERRY (sweet) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-267-15 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/15/1990 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK
