Guaifenesin

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Acesulfame Potassium Anhydrous Citric Acid Fd&c Green No. 3 Fd&c Red No. 40 Hydroxyethyl Cellulose (140 Mpa.s At 5%) Water Sodium Benzoate Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2002-09-01

Medication Information

Description

Each 5 mL (1 teaspoonful) contains:

Guaifenesin 100 mg

Uses

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

Section 42229-5

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-9450-5

Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-5780-5

WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L54670551025

L53963871025

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Expectorant

SUGAR FREE / ALCOHOL FREE

Storage

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

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 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

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).

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

Principal Display Panel

NDC 55154-9450-5

GUAIFENESIN ORAL SOLUTION USP

100 mg/5mL

5 CUPS

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.

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

Structured Label Content

Uses (USES)

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

Section 42229-5 (42229-5)

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-9450-5

Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-5780-5

WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L54670551025

L53963871025

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Expectorant

SUGAR FREE / ALCOHOL FREE

Storage (STORAGE)

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

Directions (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 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

Description (DESCRIPTION)

Each 5 mL (1 teaspoonful) contains:

Guaifenesin 100 mg

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).

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

Principal Display Panel

NDC 55154-9450-5

GUAIFENESIN ORAL SOLUTION USP

100 mg/5mL

5 CUPS

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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

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.", "42229-5": "Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-9450-5 Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-5780-5 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L54670551025 L53963871025", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Expectorant SUGAR FREE / ALCOHOL FREE", "STORAGE": "Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.", "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 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", "DESCRIPTION": "Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg", "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).", "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", "Principal Display Panel": "NDC 55154-9450-5 GUAIFENESIN ORAL SOLUTION USP 100 mg/5mL 5 CUPS", "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.", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information