Mucolyte Liquid
FDA Label NDC 57237-359

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 57237-359). 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, 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 Ingredient (in each 5mL)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Indications & Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

Warnings

Do not use

  • if you 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

  • Do not take more than 6 doses in a 24-hour period
  • Do not exceed recommended dose
    •  adults and children 12 years and over 2 to 4 teaspoonfuls (10mL to 20mL) every 4 hours
     children under 12 years ask a doctor

Other Information

  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.
  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light

Inactive Ingredients

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

Questions Or Comments

 Call 1-844-474-7464

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Mucolyte (Mucolyte)

Mucolyte (Mucolyte)

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