Guaifenesin And Dextromethorphan Hydrobromide Syrup
FDA Label NDC 58657-504

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals for the product Guaifenesin And Dextromethorphan Hydrobromide (NDC 58657-504). 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 ingredients, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial
    irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions
    to make coughs more productive

Warnings

Do not use if 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

  • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If

  • cough lasts more than 7 days or occurs with fever, rash, or
    headaches that lasts. This could be a sign of a serious condition
  • hypersensitive to any ingredients

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

  • do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

    • adults and children 12 years and over2 teaspoonfuls (TSP) every 4 hours
    children 6 to 12 years of age1 teaspoonful (TSP) every 4 hours
    children under 6 yearsDO NOT USE

Inactive Ingredients

Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Other Information

  • store at room temperature 20°-25°C (68°-77°F)
  • each 5 mL contains: sodium 3 mg

Principal Display Panel

Method Pharmaceuticals

NDC 58657-504-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grape Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Southlake, TX 76092 Rev. 02/2024

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