FDA Label for Cough And Chest Congestion Maximum Strength

View Indications, Usage & Precautions

Cough And Chest Congestion Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Genexa Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

SHAKE WELL before each use.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318

genexa.com

Made in the USA with globally sourced ingredients


Otc - Active Ingredient



Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Otc - Purpose



Purposes

Cough suppressant

Expectorant


Indications & Usage



Uses

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

    • the intensity of coughing

    • the impulse to cough to help you get to sleep


Warnings



Warnings


Otc - Ask Doctor



Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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 take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Storage And Handling



Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive Ingredient



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


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