Label: DOLOFIN INFANTIL- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53145-053-03 - Packager: Menper Distributors, Inc.
- 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 September 12, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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. - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
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KEEP OUT OF REACH OF CHILDREN
Keep this and all drugs out of the reach of children.
Overdose Warning: Taking more than the
recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center immediately. Quick medical attention is
critical even if you do not notice any signs or
symptoms. -
DOSAGE & ADMINISTRATION
Directions
• this product does not contain directions or
complete warnings for adult use.
• shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use
with this product. Do not use any other dosing
device.
• if needed, repeat dose every 4 hours while
symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed
by a doctorWeight (lb) Age (yr) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-35 2-3 1 teaspoon or 5 mL
36-47 4-5 1 1/2 teaspoons or 7.5 mL
48-59 6-8 2 teaspoons or 10 mL
60-71 9-10 2 1/2 teaspoons or 12.5 mL
72-95 11 3 teaspoons or 15 mL - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DOLOFIN INFANTIL
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-053 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 BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CITRIC ACID ACETATE (UNII: DSO12WL7AU) 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) 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:53145-053-03 1 in 1 CARTON 1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/21/2012 Labeler - Menper Distributors, Inc. (101947166)