Guaifenesin Solution
FDA Label NDC 55154-5780

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Guaifenesin (NDC 55154-5780). 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 otc - purpose, description, inactive ingredients, uses, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - 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

Otc - Purpose

Expectorant
SUGAR FREE / ALCOHOL FREE

Description

Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg

Inactive Ingredients

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL

Uses

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

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.
  • you are hypersensitive to any of the ingredients.

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.

Professional Note

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Directions

Follow dosage below or use as directed by a physician.

  • do not take more than 6 doses in any 24-hour period.
    • agedose

    adults and children 12 years and over

    10 to 20 mL
    (2 to 4 teaspoonfuls)
    every 4 hours

    children 6 years to under 12 years

    5 to 10 mL
    (1 to 2 teaspoonfuls)
    every 4 hours

    children 2 to under 6 years of age

    2.5 to 5 mL
    (½ to 1 teaspoonful)
    every 4 hours

    children under 2 years of age

    consult a physician

Storage

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Principal Display Panel

Guaifenesin Oral Solution, USP

200/10 mL

5 cups

* Please review the disclaimer below.