Label: CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 65852-003-04
- Packager: Dextrum Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 24, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
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Uses
Uses
Uses
Temporary relieves:
Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive

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warnings
Warnings
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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

- Ask a doctor before use if the child has
- Stop use
- Keep out of reach of children
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Directions
Directions
Do not take more than 6 doses in any 24 hours period
use enclosed dosing cup
Keep dosage cup for use with this product
ml= milliliters
children under 4 years of age Consult a doctor
children 4 to under 6 years of age 2.5 ml every 4 hours
children 6 to under 12 years of age 5 ml every 4 hours
Adults and children 12 years & over 10 ml every 4 hours

- Other information
- Inactive ingredients
- Questions or comments?
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Indication and usage section
Indication and usage section
Do not take more than 6 doses in any 24 hours period
use enclosed dosing cup
Keep dosage cup for use with this product
ml= milliliters
children under 4 years of age Consult a doctor
children 4 to under 6 years of age 2.5 ml every 4 hours
children 6 to under 12 years of age 5 ml every 4 hours
Adults and children 12 years & over 10 ml every 4 hours

- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65852-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) HONEY (UNII: Y9H1V576FH) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCRALOSE (UNII: 96K6UQ3ZD4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color Score Shape Size Flavor HONEY (Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65852-003-04 1 in 1 CARTON 06/22/2020 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/22/2020 Labeler - Dextrum Laboratories, Inc (007392322)

Children 4-12