Guaifenesin Oral Solution, Usp

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Citric Acid Monohydrate Methylparaben Ammonium Glycyrrhizate Potassium Citrate Anhydrous Propylene Glycol Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-20

Medication Information

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

Description

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

Uses

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

Section 50565-1

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

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

Protect from light

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.

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

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

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

Questions Or Comments

QUESTIONS OR COMMENTS

Call 1-833-537-4679

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Effective: 09/2024

Rev. 03

Guaifenesin Solution 5ml

Expectorant

Sugar Free / Dye Free / Alcohol Free

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

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

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

Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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 (STORAGE)

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

Protect from light

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.

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

Description

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

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

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

Questions Or Comments (QUESTIONS OR COMMENTS)

QUESTIONS OR COMMENTS

Call 1-833-537-4679

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Effective: 09/2024

Rev. 03

Guaifenesin Solution 5ml (Guaifenesin Solution 5mL)

Expectorant

Sugar Free / Dye Free / Alcohol Free

5 Ml Unit Dose Cup Case Label (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

10 Ml Unit Dose Cup 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

15 Ml Unit Dose Cup 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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.", "50565-1": "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": "Keep tightly closed. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). [See USP] Protect from light", "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.", "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", "Description": "Each 5mL (1 teaspoonful) contains: Guaifenesin 100mg", "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", "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", "QUESTIONS OR COMMENTS": "QUESTIONS OR COMMENTS Call 1-833-537-4679 Packaged by: Kesin Pharma Oldsmar, FL 34677 Effective: 09/2024 Rev. 03", "Guaifenesin Solution 5mL": "Expectorant Sugar Free / Dye Free / Alcohol Free", "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", "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", "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, Usp

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information