Label: KIDS COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 69676-0085-9
- 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 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
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DOSAGE & ADMINISTRATION
Directions
SHAKE WELL BEFORE USING
- do not give more than 6 doses in any 24-hour period
- use only with enclosed dose cup. Do not use with any other dosing device.
- mL = milliliter
children 6 to under 12 years 5 mL - 10 mL every 4 hours children 4 to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
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SPL UNCLASSIFIED SECTION
SHAKE WELL before each use.
Bottle is safety sealed with a perforated band around the bottle. DO NOT use if bottle seal is disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30068 | genexa.com
*This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US)
LLC, owner of the registered trademark Children’s
Robitussin® Cough & Chest Congestion DM.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
Genexa®
MEDICINE MADE CLEAN
Ages 4-11
Kids' Cough & Chest CongestionDextromethorphan HBr | Guaifenesin
Cough Suppressant - Expectorant
Cough
Mucus
Chest Congestion
Made with the same active ingredients as Children’s
Robitussin® Cough & Chest Congestion DM*
Medicine made clean
Same effective active ingredients,
but no artificial fillers.
Organic Cherry Flavor
4 FL OZ (118 mL)
Dosing cup included
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INGREDIENTS AND APPEARANCE
KIDS COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69676-0085 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 STEM (UNII: J026JA743Y) WATER (UNII: 059QF0KO0R) CITRUS FRUIT (UNII: XDK00Z8012) Product Characteristics Color brown (Golden) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69676-0085-9 1 in 1 CARTON 08/06/2023 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 08/06/2023 Labeler - Genexa Inc. (079751024)