Tussin

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Caramel Anhydrous Citric Acid Dextrose Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Menthol Water Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-09

Medication Information

Purpose

Expectorant

Description

Guaifenesin, USP 200 mg

Use(s)

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

Directions

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

■ this adult strength product is not intended for use in children under 12 years of age

■ mL = milliliter

■ measure only with dosing cup provided

■ keep dosing cup with product

Age	Dose
Adults and children 12 years and over	10 – 20 mL every 4 hours
Children under 12 years	do not use

Other Information

■ each 10 mL contains:sodium 6 mg

■ store between 20-25°C (68-77°F)

■ do not refrigerate

■ Keep carton for full directions for use

Active Ingredient(s)

Guaifenesin, USP 200 mg

Inactive Ingredients

Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments?

Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

Guaifenesin oral solution USP-118 mL

Guaifenesin oral solution USP-237 mL

When Using This Product

■ do not use more than directed

Stop Use and Ask Doctor If

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222).

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

Use(s) (USE(S))

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

Purpose (PURPOSE)

Expectorant

Directions (DIRECTIONS)

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

■ this adult strength product is not intended for use in children under 12 years of age

■ mL = milliliter

■ measure only with dosing cup provided

■ keep dosing cup with product

Age	Dose
Adults and children 12 years and over	10 – 20 mL every 4 hours
Children under 12 years	do not use

Other Information (Other information)

■ each 10 mL contains:sodium 6 mg

■ store between 20-25°C (68-77°F)

■ do not refrigerate

■ Keep carton for full directions for use

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Guaifenesin, USP 200 mg

Inactive Ingredients (Inactive ingredients)

Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments? (Questions or comments?)

Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Guaifenesin oral solution USP-118 mL

Guaifenesin oral solution USP-237 mL

When Using This Product (WHEN USING THIS PRODUCT)

■ do not use more than directed

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222).

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

[{"name": "CARAMEL", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "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": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive", "PURPOSE": "Expectorant", "DIRECTIONS": "■ do not take more than 6 doses in any 24-hour period. ■ this adult strength product is not intended for use in children under 12 years of age ■ mL = milliliter ■ measure only with dosing cup provided ■ keep dosing cup with product Age Dose Adults and children 12 years and over 10 – 20 mL every 4 hours Children under 12 years do not use", "Other information": "■ each 10 mL contains: sodium 6 mg ■ store between 20-25°C (68-77°F) ■ do not refrigerate ■ Keep carton for full directions for use", "ACTIVE INGREDIENT(S)": "Guaifenesin, USP 200 mg", "Inactive ingredients": "Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate", "Questions or comments?": "Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "PRINCIPAL DISPLAY PANEL": "Guaifenesin oral solution USP-118 mL Guaifenesin oral solution USP-237 mL", "WHEN USING THIS PRODUCT": "■ do not use more than directed", "STOP USE AND ASK DOCTOR IF": "■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.", "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 (1-800-222-1222).", "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