Kids Cough And Chest Congestion Suspension
FDA Label NDC 69676-0037

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Kids Cough And Chest Congestion (NDC 69676-0037). 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.

Label Section Quick Index

Other

Drug Facts

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Los Angeles, CA 90034 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0037-9

Otc - Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Otc - Purpose

Purposes

Cough suppressant

Expectorant

Indications & Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings

Otc - Ask Doctor

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

Otc - Stop Use

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.

Dosage & Administration

Directions

  • 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 years5 mL - 10 mL every 4 hours
    children 4 to under 6 years2.5 mL - 5 mL every 4 hours
    children under 4 yearsdo not use

Storage And Handling

Other information

store between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, non-GMO flavor, purified water

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