Guaifenesin Liquid
FDA Label NDC 83720-503

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncor Pharmaceuticals for the product Guaifenesin (NDC 83720-503). 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 teaspoonful), purpose, uses, 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., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml Teaspoonful)

Guaifenesin 100 mg

Purpose

Expectorant

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • do not take more than 6 doses in any 24-hour period
     Age   Dose
     Adults and Children 12 years and over 2-4 Teaspoonfuls every 4 hours
     Children 6 years to under 12 years 1-2 Teaspoonfuls every 4 hours
     Children 2 years to under 6 years 1/2-1 Teaspoonful every 4 hours
     Under 2 years Ask a doctor

    • Drug Facts(continued)

Other Information

  • store at 20°-25°C (68°-77°F)
  • Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
  • sodium content 3 mg/5 mL

Inactive Ingredients

Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Manufactured for:
Oncor Pharmaceuticals
8815 Center Park Dr. Suite 430
Columbia, Maryland 21045


Rev. 05/24

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