Guaifenesin Syrup And Dextromethorphan

Guaifenesin Syrup And Dextromethorphan
SPL v6
SPL
SPL Set ID ad9026f4-f0b6-4d02-aa44-f0460eeefc0e
Route
ORAL
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose Fd&c Red No. 40 Menthol Glycerin High Fructose Corn Syrup Water Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-19
Description

Non-Narcotic - Alcohol Free

Medication Information

Dosage and Administration

DIRECTIONS:

Age Dose
Adults and children

12 years and over

10 mL every 4 hours

Max dose is 60mL in 24-hours
Children under 12 years of age Ask a doctor

Dosage Forms and Strengths

HOW SUPPLIED: 

Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

NDC 69339-149-05 (1) unit dose cup 5mL

NDC 69339-149-19 100 (10x10) unit dose cups 5mL



Each 10 mL of Guaifenesin Syrup and Dextromethorphan

contains Guaifenesin 200mg and Dextromethorphan

Hydrobromide 20mg and is supplied in the following oral

dosage forms:

NDC 69339-150-01 (1) unit dose cup 10mL

NDC 69339-150-19 100 (10x10) unit dose cups 10mL

Description

Non-Narcotic - Alcohol Free

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

Questions or comments?

Call 201-786-6500

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DP-UD-PI-AT-[117893] Rev 08/20

Section 44425-7

Other Information

• Store at controlled room temperature 20-25ºC (68-77ºF)

• Do not refrigerate

• Keep tightly closed

• Each 5mL contains sodium 3mg

• Each 10mL contains sodium 6mg

• Fruit punch flavor

• Do not use if lid seal is open or damaged

• See top of cup for lot number and expiration date

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Section 50570-1

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.

Section 53414-9

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

Section 55105-1

Non-Narcotic - Alcohol Free

Drug Facts

Active Ingredient (in each 5 mL cup)                                                                                                                    Purpose

Guaifenesin, USP 100mg .............................................................................................................................. Expectorant

Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant

Active Ingredient (in each 10 mL cup)                                                                                                                   Purpose

Guaifenesin, USP 200mg .............................................................................................................................. Expectorant

Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant

Inactive Ingredients

Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified  water, saccharin sodium, sodium benzoate.

Stop Use and Ask A Doctor If

• your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

• 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

Ask a doctor or pharmacist before use if you are taking any other drug

Principal Display Panel 5 Ml Unit Dose Cup Label

Delivers 5 mL

NDC 69339-149-05

GUAIFENESIN SYRUP &

DEXTROMETHORPHAN HBr

100 mg/10 mg per 5 mL

For Institutional Use Only

3 69339 14905 8

Lot # 111

Exp: 09/22/2020

See Insert

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

Principal Display Panel 10 Ml Unit Dose Cup Label

Delivers 10 mL

NDC 69339-150-01

GUAIFENESIN SYRUP &

DEXTROMETHORPHAN HBr

200 mg/20 mg per 10 mL

For Institutional Use Only

3 69339 15001 6

Lot # 111

Exp: 09/22/2020

See Insert

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

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.

Dosage and Administration (34068-7)

DIRECTIONS:

Age Dose
Adults and children

12 years and over

10 mL every 4 hours

Max dose is 60mL in 24-hours
Children under 12 years of age Ask a doctor

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: 

Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

NDC 69339-149-05 (1) unit dose cup 5mL

NDC 69339-149-19 100 (10x10) unit dose cups 5mL



Each 10 mL of Guaifenesin Syrup and Dextromethorphan

contains Guaifenesin 200mg and Dextromethorphan

Hydrobromide 20mg and is supplied in the following oral

dosage forms:

NDC 69339-150-01 (1) unit dose cup 10mL

NDC 69339-150-19 100 (10x10) unit dose cups 10mL

Section 42229-5 (42229-5)

Questions or comments?

Call 201-786-6500

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DP-UD-PI-AT-[117893] Rev 08/20

Section 44425-7 (44425-7)

Other Information

• Store at controlled room temperature 20-25ºC (68-77ºF)

• Do not refrigerate

• Keep tightly closed

• Each 5mL contains sodium 3mg

• Each 10mL contains sodium 6mg

• Fruit punch flavor

• Do not use if lid seal is open or damaged

• See top of cup for lot number and expiration date

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 (1-800-222-1222)

Section 50570-1 (50570-1)

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.

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

Drug Facts (DRUG FACTS)

Active Ingredient (in each 5 mL cup)                                                                                                                    Purpose

Guaifenesin, USP 100mg .............................................................................................................................. Expectorant

Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant

Active Ingredient (in each 10 mL cup)                                                                                                                   Purpose

Guaifenesin, USP 200mg .............................................................................................................................. Expectorant

Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant

Inactive Ingredients

Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified  water, saccharin sodium, sodium benzoate.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

• 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

Ask a doctor or pharmacist before use if you are taking any other drug

Principal Display Panel 5 Ml Unit Dose Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label)

Delivers 5 mL

NDC 69339-149-05

GUAIFENESIN SYRUP &

DEXTROMETHORPHAN HBr

100 mg/10 mg per 5 mL

For Institutional Use Only

3 69339 14905 8

Lot # 111

Exp: 09/22/2020

See Insert

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

Principal Display Panel 10 Ml Unit Dose Cup Label (PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label)

Delivers 10 mL

NDC 69339-150-01

GUAIFENESIN SYRUP &

DEXTROMETHORPHAN HBr

200 mg/20 mg per 10 mL

For Institutional Use Only

3 69339 15001 6

Lot # 111

Exp: 09/22/2020

See Insert

Dash Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:11.598092 · Updated: 2026-03-14T23:01:38.303933