Dextromethorphan Hydrobromide And Guaifenesin Syrup
FDA Label NDC 69729-812

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 69729-812). 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, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

  • Cough suppressant
  • 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

Do Not Use

  • Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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

Stop Use And Ask A Doctor If

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

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