DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

Citric Acid Fd&c Red No. 40 Glycerin Menthol Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Strawberry

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-20

Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr. USP 10 mg Guaifenesin USP 100 mg

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 50565-1

Warnings

Do not useif 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.

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

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

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

Directions

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

Adults and Children 12 years of age and over	10mL (2 teaspoonfuls every 4 hours or as directed by doctor)
Children under 12 years of age	Do not use

Product Label

Other Information

store at room temperature
15° to 30°C (59° to 86°F) TAMPER-EVIDENT;
do not use if seal under cap is torn broken or missing.

Inactive Ingredients

CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE

Active Ingredient (in Each 5ml Tsp)

Dextromethorphan HBr. USP 10 mg

Guaifenesin USP 100 mg

Questions Or Comments? 1 888 462 4166

Structured Label Content

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 50565-1 (50565-1)

Purpose

Cough Suppressant

Expectorant

Warnings

Do not useif 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.

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

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

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

Directions

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

Adults and Children 12 years of age and over	10mL (2 teaspoonfuls every 4 hours or as directed by doctor)
Children under 12 years of age	Do not use

Product Label (Product label)

Other Information

store at room temperature
15° to 30°C (59° to 86°F) TAMPER-EVIDENT;
do not use if seal under cap is torn broken or missing.

Inactive Ingredients

CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE

Active Ingredient (in Each 5ml Tsp) (Active Ingredient (in each 5mL tsp))

Dextromethorphan HBr. USP 10 mg

Guaifenesin USP 100 mg

Questions Or Comments? 1 888 462 4166 (Questions or Comments? 1-888-462-4166)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "Purpose": "Cough Suppressant Expectorant", "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. 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 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. If pregnant or breast-feeding , ask a healthcare professional before use. Keep out of reach of children . In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Directions": "do not take more than 6 doses in any 24 hour period Adults and Children 12 years of age and over 10mL (2 teaspoonfuls every 4 hours or as directed by doctor) Children under 12 years of age Do not use", "Other Information": "store at room temperature 15° to 30°C (59° to 86°F) TAMPER-EVIDENT; do not use if seal under cap is torn broken or missing.", "Inactive Ingredients": "CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE", "Active Ingredient (in each 5mL tsp)": "Dextromethorphan HBr. USP 10 mg Guaifenesin USP 100 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information