Dextromethorphan Hydrobromide And Guaifenesin Syrup
FDA Label NDC 69729-069

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Dextromethorphan Hydrobromide And Guaifenesin (NDC 69729-069). 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 active ingredient (in each 5 ml)                      purpose, uses, ask a doctor before use if you have, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)                      Purpose

Dextromethorphan HBr USP 10 mg............. Cough suppressant

Guaifenesin, USP 100 mg............................... Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Ask A Doctor Before Use If You Have

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

Directions

  • take evey 4 hours
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product

    • Age

    Dose

    Adults and children 12 years and over

    2 teaspoonful (10 mL)

    Children 6 to under 12 years

    1 teaspoonful (5 mL)

    Children under 6 years

    Ask a doctor

Other Information

  • Store at 20°-25°C (68° -77°F). 
  • Do not refrigerate.
  • Retain carton for future reference on full labeling

Inactive Ingredients

citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.

Principal Display Panel

Container_035 (Container 035)

Container_035 (Container 035)

Container_036 (Container 036)

Container_036 (Container 036)

Container_069 (Container 069)

Container_069 (Container 069)

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