Guaifenesin And Dextromethorphan Syrup

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 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 2024-08-04

Medication Information

Purpose

Expectorant

Cough Suppressant

Description

Guaifenesin 200 mg Dextromethorphan Hydrobromide 20 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).

Distributed by:

American Health Packaging

Columbus, OH 43217

R0324

Warnings

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.

Directions

Follow dosage below or use as directed by a physician.

do not take more than 6 doses in any 24-hour period.

Age (yr)	Dose (mL)
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

Other Information

Each 10 mL contains: sodium 8 mg
Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
DO NOT USE IF SEAL IS BROKEN.
Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms:

5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17

10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56

Inactive Ingredients

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

Questions Or Comments?

Call 1-800-845-8210

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.

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

Active Ingredient (in Each 10 Ml Cup)

Guaifenesin 200 mg

Dextromethorphan Hydrobromide 20 mg

Package/label Principal Display Panel Label

Case NDC 60687-828-56/Cup NDC 60687-828-42

GUAIFENESIN and

DEXTROMETHORPHAN

SYRUP

Expectorant/Cough Suppressant

200 mg/20 mg per 10 mL

Non-Narcotic, Alcohol Free

Cherry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0638C100324 R03/24

Package/label Principal Display Panel – Cup Lid – 200 Mg/20 Mg Per 10 Ml

NDC 60687- 828-42

Guaifenesin and

Dextromethorphan Syrup

Expectorant/cough Suppressant

200 mg/20 mg per 10 mL

Sodium Content: 8 mg/10 mL

Delivers 10 mL

Protect from light

See package Drug Facts insert for full

prescribing information and storage

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0638C100224

Structured Label Content

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 (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).

Distributed by:

American Health Packaging

Columbus, OH 43217

R0324

Purpose

Expectorant

Cough Suppressant

Warnings

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.

Directions

Follow dosage below or use as directed by a physician.

do not take more than 6 doses in any 24-hour period.

Age (yr)	Dose (mL)
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

Other Information

Each 10 mL contains: sodium 8 mg
Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
DO NOT USE IF SEAL IS BROKEN.
Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms:

5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17

10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56

Inactive Ingredients

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

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

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

Active Ingredient (in Each 10 Ml Cup) (Active ingredient (in each 10 mL Cup))

Guaifenesin 200 mg

Dextromethorphan Hydrobromide 20 mg

Package/label Principal Display Panel Label (Package/Label Principal Display Panel - Label)

Case NDC 60687-828-56/Cup NDC 60687-828-42

GUAIFENESIN and

DEXTROMETHORPHAN

SYRUP

Expectorant/Cough Suppressant

200 mg/20 mg per 10 mL

Non-Narcotic, Alcohol Free

Cherry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]

Protect from light.

FOR INSTITUTIONAL USE ONLY

T0638C100324 R03/24

Package/label Principal Display Panel – Cup Lid – 200 Mg/20 Mg Per 10 Ml (Package/Label Principal Display Panel – Cup Lid – 200 mg/20 mg per 10 mL)

NDC 60687- 828-42

Guaifenesin and

Dextromethorphan Syrup

Expectorant/cough Suppressant

200 mg/20 mg per 10 mL

Sodium Content: 8 mg/10 mL

Delivers 10 mL

Protect from light

See package Drug Facts insert for full

prescribing information and storage

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0638C100224

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "unii": "9D2RTI9KYH", "classCode": "ACTIR", "strengthNumerator": "20", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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", "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). Distributed by: American Health Packaging Columbus, OH 43217 R0324", "Purpose": "Expectorant Cough Suppressant", "Warnings": "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.", "Directions": "Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. Age (yr) Dose (mL) 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", "Other Information": "Each 10 mL contains: sodium 8 mg Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms: 5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17 10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56", "Inactive Ingredients": "citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.", "Questions or comments?": "Call 1-800-845-8210", "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.", "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", "Active ingredient (in each 10 mL Cup)": "Guaifenesin 200 mg Dextromethorphan Hydrobromide 20 mg", "Package/Label Principal Display Panel - Label": "Case NDC 60687-828-56/Cup NDC 60687-828-42 GUAIFENESIN and DEXTROMETHORPHAN SYRUP Expectorant/Cough Suppressant 200 mg/20 mg per 10 mL Non-Narcotic, Alcohol Free Cherry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0638C100324 R03/24", "Package/Label Principal Display Panel – Cup Lid – 200 mg/20 mg per 10 mL": "NDC 60687- 828 -42 Guaifenesin and Dextromethorphan Syrup Expectorant/cough Suppressant 200 mg/20 mg per 10 mL Sodium Content: 8 mg/10 mL Delivers 10 mL Protect from light See package Drug Facts insert for full prescribing information and storage For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0638C100224"}

Guaifenesin And Dextromethorphan Syrup

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information