Label: CHILDRENS GILTUSS HONEY DM COUGH- dextromethorphan hbr solution
- NDC Code(s): 58552-144-04
- Packager: Gil Pharmaceutical Corp
- 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.
Updated January 29, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Do not use if your child is now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough such as occurs with asthma
Stop use and ask a doctor if the child has a cough that lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
DOSAGE & ADMINISTRATION
- do not take more than 4 doses in any 24-hour period
- use enclosed dosing cup
- keep dosage cup for use with this product
- ml = milliliters
children under 4 years Consult a doctor children 4 to under 6 years 2.5 mL every 6-8 hours children 6 to under 12 years 5 mL every 6-8 hours children 12 years and over 10 mL every 6-8 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CHILDRENS GILTUSS HONEY DM COUGH
dextromethorphan hbr solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-144 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) HONEY (UNII: Y9H1V576FH) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color yellow (Light yellow) Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-144-04 1 in 1 CARTON 06/22/2020 1 118 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 06/22/2020 Labeler - Gil Pharmaceutical Corp (176826592)