Label: KIDS COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 69676-0037-9
- Packager: Genexa Inc.
- 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.
Drug Label Information
Updated August 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not use in a child who is 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’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
Genexa
MEDICINE MADE CLEAN
Kids' Cough & Chest CongestionDextromethorphan HBr | Guaifenesin
Cough Suppressant - Expectorant
Cough
Mucus
Chest Congestion
Medicine made clean
Same effective active ingredients, but no artificial fillers.
Organic Blueberry Flavor
4 FL OZ (118 mL) Liquid
Dosing cup included
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INGREDIENTS AND APPEARANCE
KIDS COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69676-0037 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength AGAVE TEQUILANA JUICE (UNII: GVG8G0207O) WATER (UNII: 059QF0KO0R) CITRUS FRUIT (UNII: XDK00Z8012) BLUEBERRY (UNII: 253RUG1X1A) Product Characteristics Color brown (Golden) Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69676-0037-9 1 in 1 CARTON 07/01/2020 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 final part341 07/01/2020 Labeler - Genexa Inc. (079751024)