Label: DEFENSOLITO CHILDREN SYRUP- guaifenesin, dextromethorphan hbr liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 53145-008-04 - Packager: Menper Distributors, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 15mL tsp)
- Purpose
- Uses
- Warnings Do not exceed recommended dosage.
-
Do not use:
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI ask a doctor or a pharmacist giving this product.
- this product for persistent or chronic cough such as occur with asthma, or if cough is accompanied ny excessive phlegm (mucus) unless directed by a doctor.
- Keep this and all drugs out of the reach of children
- Directions
- Other information
- Inactive ingredients
- Question?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DEFENSOLITO CHILDREN SYRUP
guaifenesin, dextromethorphan hbr liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) D&C RED NO. 33 (UNII: 9DBA0SBB0L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) RASPBERRY (UNII: 4N14V5R27W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-008-04 1 in 1 CARTON 02/21/2012 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/21/2012 Labeler - Menper Distributors, Inc. (101947166)