Guaifenesin Dm

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Water Sodium Benzoate Sodium Citrate, Unspecified Form Saccharin Sodium Sucrose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 1992-07-01

Medication Information

Dosage and 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 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years	2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 years	ask a doctor

Description

Each 5 mL (1 teaspoonful) contains:
Guaifenesin	100 mg
Dextromethorphan Hydrobromide	10 mg

Uses

•
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
•
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Section 42229-5

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).

Section 44425-7

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

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 50570-1

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 51727-6

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Sodium Content: 4 mg/5 mL

Section 53414-9

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

Section 55105-1

Non-Narcotic, Alcohol Free

Expectorant/Cough Suppressant

Manufactured By

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L54670891225

R11/16

Principal Display Panel

NDC 55154-5785-5

GUAIFENESIN SYRUP AND

DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

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
•
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Dosage and Administration (34068-7)

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 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years	2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 years	ask a doctor

Section 42229-5 (42229-5)

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).

Section 44425-7 (44425-7)

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

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 50570-1 (50570-1)

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 51727-6 (51727-6)

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Sodium Content: 4 mg/5 mL

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Non-Narcotic, Alcohol Free

Expectorant/Cough Suppressant

Description (DESCRIPTION)

Each 5 mL (1 teaspoonful) contains:
Guaifenesin	100 mg
Dextromethorphan Hydrobromide	10 mg

Manufactured By (MANUFACTURED BY)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L54670891225

R11/16

Principal Display Panel

NDC 55154-5785-5

GUAIFENESIN SYRUP AND

DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

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 • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold", "34068-7": "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 mL (2 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years ask a doctor", "42229-5": "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).", "44425-7": "STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light. ", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "51727-6": "Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant", "DESCRIPTION": "Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg Dextromethorphan Hydrobromide 10 mg", "MANUFACTURED BY": "Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com Distributed By: Cardinal Health Dublin, OH 43017 L54670891225 R11/16", "Principal Display Panel": "NDC 55154-5785-5 GUAIFENESIN SYRUP AND DEXTROMETHORPHAN 100 mg/10 mg per 5 mL 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