Label: CHILDRENS GILTUSS EX EXPECTORANT- guaifenesin solution
- NDC Code(s): 65852-016-04
- Packager: Dextrum Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 24, 2025
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
- Stop use section
- 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= mililiters
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 for use section
indication an user 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= mililiters
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 EX EXPECTORANT
guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65852-016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) CITRIC ACID (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor TUTTI FRUTTI Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65852-016-04 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)
