Mucolyte Liquid
FDA Label NDC 57237-360

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Mucolyte (NDC 57237-360). 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 drug facts, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Dextromethorphan Hydrobromide, USP 10 mg

Otc - Purpose

Purposes

Expectorant

Cough Suppressant

Indications & Usage

Uses

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

Warnings

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.

Do not use if you have ever had an allergic reaction to any of the ingredients in 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 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Dosage & Administration

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
    •  adults and children 12 years and over 2 teaspoonfuls (10 mL)
     children under 12 years do not use

Other Information

  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
  • do not refrigerate
  • TAMPER-EVIDENT: Do not use if foil seal over bottle is torn, broken or missing
  • Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP

Inactive Ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, menthol, propylene glycol, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose, water.

Questions Or Comments

Call 1-844-474-7464

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Mucolyte-dm (Mucolyte Dm)

Mucolyte-dm (Mucolyte Dm)

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