Label: GILTUSS HONEY DM COUGH- dextromethorphan hbr solution
- NDC Code(s): 58552-143-04
- 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 you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if cough 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
adults and children 12 years and over 10 mL every 6-8 hours children 6 to under 12 years of age 5 mL every 6-8 hours children 4 to under 6 years of age 2.5 mL every 6-8 hours children under 4 years of age Consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GILTUSS HONEY DM COUGH
dextromethorphan hbr solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-143 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 10 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:58552-143-04 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)