Sda-tussindm 565

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

Menthol Anhydrous Citric Acid Fd&c Red No. 40 Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Sucrose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-01

Medication Information

Warnings and Precautions

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.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

a cough with too much phlegm (mucus)
a 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 headache that lasts. These could be signs of a serious condition.

Indications and Usage

Uses

temporarilyrelievescoughduetominorthroatand bronchial irritation
helps loosen phlegm (mucus)
helps thin bronchial secretions to make coughs more productive

Dosage and Administration

Directions

take every 4 hours as needed, or as directed by a doctor
do not take more than 6 doses in 24 hours
do not exceed recommended dose

Adults and children 12 years and over	2 teaspoonfuls (10 mL)
Children under 12 years	do not use

Description

per 5 mL teaspoonful Dextromethorphan HBr - 10 mg Guaifenesin - 100 mg

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 51727-6

Inactive ingredients:artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose

Section 51945-4

Section 53413-1

Questions or Comments? 1-203-861-0005

Section 53414-9

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

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

per 5 mL teaspoonful

Dextromethorphan HBr - 10 mg

Guaifenesin - 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarilyrelievescoughduetominorthroatand bronchial irritation
helps loosen phlegm (mucus)
helps thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

Directions

take every 4 hours as needed, or as directed by a doctor
do not take more than 6 doses in 24 hours
do not exceed recommended dose

Adults and children 12 years and over	2 teaspoonfuls (10 mL)
Children under 12 years	do not use

Warnings and Precautions (34071-1)

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.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

a cough with too much phlegm (mucus)
a 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 headache that lasts. These could be signs of a serious condition.

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 51727-6 (51727-6)

Inactive ingredients:artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-203-861-0005

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

per 5 mL teaspoonful

Dextromethorphan HBr - 10 mg

Guaifenesin - 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarilyrelievescoughduetominorthroatand bronchial irritation helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive", "34068-7": "Directions take every 4 hours as needed, or as directed by a doctor do not take more than 6 doses in 24 hours do not exceed recommended dose Adults and children 12 years and over 2 teaspoonfuls (10 mL) Children under 12 years do not use", "34071-1": "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. Do not use if you have ever had an allergic reaction to any of the ingredients in this product. Ask a doctor before use if you have a cough with too much phlegm (mucus) a 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 headache that lasts. These could be signs of a serious condition.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose", "53413-1": "Questions or Comments? 1-203-861-0005", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Cough Suppressant Expectorant", "55106-9": "per 5 mL teaspoonful Dextromethorphan HBr - 10 mg Guaifenesin - 100 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information