Kids Cough And Chest Congestion
FDA Label NDC 69676-0085

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 69676-0085). 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

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.

Made in the USA with globally sourced ingredients

NDC 69676-0085-9

Otc - Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 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

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 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 ingredientsorganic agave syrup, organic cherry flavor, natural citrus extract, natural flavor, purified water

* Please review the disclaimer below.