Guaifenesin GUAIFENESIN KESIN PHARMA CORPORATION FDA Approved Uses Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Drug Facts

Composition & Profile

Active Ingredients
Description Each 5mL (1 teaspoonful) contains: Guaifenesin 100mg
Inactive Ingredients
Inactive Ingredients Mixture of Guaifenesin with GRAS material additions including Citric Acid Grape Flavor Methylparaben Monoammonium Glycyrrhizate Potassium Citrate Propylene Glycol Propylparaben Purified Water Sorbitol Sucralose
Strengths
5 ml 100 unit 50 unit 10 ml 15 ml 100 mg
Quantities
5 ml 10 ml 15 ml
Treats Conditions
Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Make Coughs More Productive

Identifiers & Packaging

Container Type BOX
UNII
495W7451VQ
Packaging

How Supplied: Guaifenesin Oral Solution is a clear, colorless solution with a grape flavor, free of visible foreign matter supplied in the following oral dosage forms: NDC 81033-102-05: 5mL unit dose cup NDC 81033-102-51: Case containing 100 unit dose cups of 5 mL packaged in 2 cartons of 50 unit dose cups each NDC 81033-102-10: 10mL unit dose cup NDC 81033-102-52: Case containing 100 unit dose cups of 10 mL packaged in 2 cartons of 50 unit dose cups each NDC 81033-102-15: 15 mL unit dose cup NDC 81033-102-53: Case containing 100 unit dose cups of 15 mL packaged in 2 cartons of 50 unit dose cups each; 5 mL Unit Dose Cup Case Label NDC 81033-102-51 Guaifenesin Oral Solution, USP100 mg/5 mL Delivers 5 mL Case = 100 UD Cups (Do Not Break Case) Store at 68°F to 77°F (20°C to 25°C) QTY 1 Guaifenesin Oral Solution 5 mL Case Label; 10 mL Unit Dose Cup Case Label NDC 81033-102-52 Guaifenesin Oral Solution, USP 200 mg/10 mL Delivers 10 mL Case = 100 UD Cups (Do Not Break Case) Store at 68°F to 77°F (20°C to 25°C) QTY 1 Guaifenesin Oral Solution 10 mL Case Label; 15 mL Unit Dose Cup Case Label NDC 81033-102-53 Guaifenesin Oral Solution, USP 300 mg/15 mL Delivers 15 mL Case = 100 UD Cups (Do Not Break Case) QTY 1 Guaifenesin Oral Solution 15 mL Case Label

Package Descriptions
  • How Supplied: Guaifenesin Oral Solution is a clear, colorless solution with a grape flavor, free of visible foreign matter supplied in the following oral dosage forms: NDC 81033-102-05: 5mL unit dose cup NDC 81033-102-51: Case containing 100 unit dose cups of 5 mL packaged in 2 cartons of 50 unit dose cups each NDC 81033-102-10: 10mL unit dose cup NDC 81033-102-52: Case containing 100 unit dose cups of 10 mL packaged in 2 cartons of 50 unit dose cups each NDC 81033-102-15: 15 mL unit dose cup NDC 81033-102-53: Case containing 100 unit dose cups of 15 mL packaged in 2 cartons of 50 unit dose cups each
  • 5 mL Unit Dose Cup Case Label NDC 81033-102-51 Guaifenesin Oral Solution, USP100 mg/5 mL Delivers 5 mL Case = 100 UD Cups (Do Not Break Case) Store at 68°F to 77°F (20°C to 25°C) QTY 1 Guaifenesin Oral Solution 5 mL Case Label
  • 10 mL Unit Dose Cup Case Label NDC 81033-102-52 Guaifenesin Oral Solution, USP 200 mg/10 mL Delivers 10 mL Case = 100 UD Cups (Do Not Break Case) Store at 68°F to 77°F (20°C to 25°C) QTY 1 Guaifenesin Oral Solution 10 mL Case Label
  • 15 mL Unit Dose Cup Case Label NDC 81033-102-53 Guaifenesin Oral Solution, USP 300 mg/15 mL Delivers 15 mL Case = 100 UD Cups (Do Not Break Case) QTY 1 Guaifenesin Oral Solution 15 mL Case Label

Overview

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

Indications & Usage

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

Dosage & Administration

Directions Follow dosage below or use as directed by a physician. • Do not take more than 6 doses in any 24-hour period Age Dose Adults and children 12 years and over 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours Children 6 years to under 12 years 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours Children 2 to under 6 years of age 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours Children under 2 years of age Consult a physician

Warnings & Precautions
Warnings Ask a doctor before us 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 and ask a doctor if • cough lasts mor 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.
Purpose

Guaifenesin Solution 5mL Expectorant Sugar Free / Dye Free / Alcohol Free

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).

Storage & Handling

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

Questions

QUESTIONS OR COMMENTS QUESTIONS OR COMMENTS Call 1-833-537-4679 Packaged by: Kesin Pharma Oldsmar, FL 34677 Effective: 09/2024 Rev. 03 Kesin Pharma Logo


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