The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Kids Cough And Chest Congestion (NDC 69676-0106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
*When compared to the ingredient profiles in the leading brands’ top-selling comparable products. (FRC 2025)
SHAKE WELL BEFORE EACH USE
DO NOT use if perforated band around the bottle or seal under the cap is disturbed or missing.
Distributed by: Genexa Inc.
Atlanta, GA 30324 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0106-9
Active ingredients
(in each 5 mL)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Purposes
Cough suppressant
Expectorant
Uses
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
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)
Directions
| Age | Dose |
| 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 |
Other information
store between 20-25°C (68-77°F)
Inactive Ingredients
agave syrup (organic), citric acid (natural), flavors (organic blueberry and natural), glycerin (natural), purified water, xylitol (natural)
Questions? 1-855-436-3921
Pediatrician Preferred #1 INGREDIENTS*
Genexa
CLEAN MEDICINE
Ages 4-11
Kids DAYTIME Cough & Chest Congestion
Dextromethorphan HBr | Cough Suppressant
Guaifenesin | Expectorant
Cough, Mucus, Chest Congestion
0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens
Made with Real Agave + Blueberry flavoring
4 FL OZ (118 mL)
153a_carton_r-20260421 (153a Carton R 20260421)
* Please review the disclaimer below.
