Guaifenesin
FDA Label NDC 50383-063

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akorn for the product Guaifenesin (NDC 50383-063). 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, inactive ingredients, 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Each 5 mL (1 teaspoonful) contains:

Guaifenesin ................................................ 100 mg

Inactive Ingredients

Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

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.
  • you are hypersensitive to any of the ingredients

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.

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 over10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
    children 6 years to under 12 years5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
    children 2 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
    children under 2 years of ageask a doctor

    How Supplied:

    Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

    Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage

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

Questions Or Comments?

Call 1-800-262-9010.


Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701


Rev.063:00 10/10

MG #29850

Package/Label Principal Display Panel

Lid_063_15 mL (4d939198 A09c 46b0 A8fe Fc2b09b5177d 01)

Lid_063_15 mL (4d939198 A09c 46b0 A8fe Fc2b09b5177d 01)

Delivers 15 mL

NDC 50383-063-15

GUAIFENESIN ORAL SOLUTION

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 063:00 10/10

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