Label: GILTUSS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
- NDC Code(s): 65852-012-04
- Packager: Dextrum Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 18, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Purpouse Section & Uses
Cough supressant
Expectorant
Nasal Descongestant
Uses
temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold.

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Warnings
Warnings
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 dont know if your prescription drug contains and MAOI , ask a doctor or pharmacist before taking this product,

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Ask a Doctor
Ask a doctor before use if you have, heart disease, high blood pressure, thryroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor, cough with too much phlegm ( mucus), a persistent or chronic cough as occurs with smoking, asthma,chronic bronchitis, or ephysema

- Ask a doctor or pharmacist
- Stop use
- Pregnancy or breast feeding
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Directions
Directions, do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.
Adults and children 12 years & over 5 ml every 4 hours
children 6 to under 12 years age 2.5 ml every 4 hours
children 4 to 6 years of age 1.25 ml every 4 hours
children under 6 years of age Consult a doctor

- other information
- Inactive Ingredients
- Questions
- Keep out of reach of children
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Indication and usage section
Indication and usage section
Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.
Adults and children 12 years & over 5 ml every 4 hours
children 6 to under 12 years age 2.5 ml every 4 hours
children 4 to 6 years of age 1.25 ml every 4 hours
children under 6 years of age Consult a doctor

- Principal panel
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INGREDIENTS AND APPEARANCE
GILTUSS COUGH AND COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65852-012 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 300 mg in 5 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D) SORBITOL SOLUTION (UNII: 8KW3E207O2) CITRIC ACID (UNII: 2968PHW8QP) SUCRALOSE (UNII: 96K6UQ3ZD4) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65852-012-04 1 in 1 CARTON 10/02/2018 1 113 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 10/02/2018 Labeler - Dextrum Laboratories Inc. (007392322)


