Kids Cough Daytime Nighttime Combo
FDA Label NDC 69676-0090

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 Daytime Nighttime Combo (NDC 69676-0090). 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

Kids' Cough & Chest Congestion

Drug Facts

**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.

Kids' Nighttime Cough

Drug Facts

**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Nighttime Cough Long-Acting DM.

SHAKE WELL before each use.

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 30324 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0090-9

Otc - Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Active Ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, 15 mg

Otc - Purpose

Purposes

Cough suppressant

Expectorant

Purposes

Antihistamine

Cough suppressant

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

Uses


• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose • sneezing • itchy, watery eyes

• itching of the nose or throat

Warnings

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

    • Ask a doctor before use if you have


    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

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.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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
    • AgeDose
    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

    Directions

    • SHAKE WELL BEFORE USING
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 4 doses in any 24-hour period
      • AgeDose

      Adults and children

      12 years and older

      20 mL every

      6 hours

      Children 6 to under 12

      years

      		10 mL every 6 hours
      Children under 6 yearsdo not use

Storage And Handling

Other information

store between 20-25°C (68-77°F)

Other information

store between 20-25°C (68-77°F)

Inactive Ingredient

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

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water

* Please review the disclaimer below.