The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Childrens Cough And Chest Congestion (NDC 69676-0070). 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
*This product is not manufactured or distributed by PF CONSUMER HEALTHCARE 1 LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0070-9
Active ingredients
(in each 5 mL)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Purpose
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.
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 a Poison Control Center right away.
(1-800-222-1222)
Directions
| 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
organic agave syrup, organic blueberry flavor, natural citrus extract, flavor, purified water
Questions? 1-855-436-3921
Children's
Genexa®
MEDICINE MADE CLEAN
Ages 4-11
Cough & Chest Congestion
Dextromethorphan HBr | Guaifenesin
Cough Suppressant - Expectorant
Mucus
Chest Congestion
Compare to active ingredients in Children's Robitussin® Cough & Chest Congestion DM*
How we're different
Made without: sodium benzoate, propylene glycol, sucralose & more!
Organic Blueberry Flavor
4 fl oz (118 mL) Dosing cup included
Gnx-153_cough-and-chest-congestion_childrens_carton_r-2022_01_14 (Gnx 153 Cough And Chest Congestion Childrens Carton R 2022 01 14)
* Please review the disclaimer below.
