drug facts

Composition & Product

Active Ingredients

dextromethorphan (10 mg) guaifenesin (100 mg)

Inactive Ingredients

anhydrous citric acid dextrose fd&c red no. 40 high fructose corn syrup menthol saccharin sodium sodium benzoate water glycerin

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

otc monograph final active Since 1999-03-16

Medication Information

Purpose

Cough suppressant

Expectorant

Directions

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

age	dose
adults and children 12 years of age and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years of age	1 teaspoonful every 4 hours
children 2 years to under 6 years of age	1/2 teaspoonful every 4 hours
under 2 years of age	ask a doctor

Other Information

•
store at room temperature 15º - 30ºC (59º - 86ºF)
•
protect from freezing.
•
protect from light.
•
Each teaspoon (5 mL) contains: sodium 2 mg.
•
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive Ingredients

citric acid, FD&C Red #40, flavors, glucose, glycerin, high fructose corn syrup, menthol, saccharin sodium, sodium benzoate, water

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Principal Display Panel

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold

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

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 50566-9

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.

Section 50569-3

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

Section 53414-9

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

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.

Active Ingredients (in Each 5 Ml)(one Teaspoonful)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Structured Label Content

Purpose

Cough suppressant

Expectorant

Directions

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

age	dose
adults and children 12 years of age and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years of age	1 teaspoonful every 4 hours
children 2 years to under 6 years of age	1/2 teaspoonful every 4 hours
under 2 years of age	ask a doctor

Other Information (Other information)

•
store at room temperature 15º - 30ºC (59º - 86ºF)
•
protect from freezing.
•
protect from light.
•
Each teaspoon (5 mL) contains: sodium 2 mg.
•
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Red #40, flavors, glucose, glycerin, high fructose corn syrup, menthol, saccharin sodium, sodium benzoate, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold

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

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 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Do Not Use (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.

Active Ingredients (in Each 5 Ml)(one Teaspoonful) (Active ingredients (in each 5 mL)(one teaspoonful))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50569-3": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Cough suppressant Expectorant", "Directions": "do not take more than 6 doses in any 24-hour period age dose adults and children 12 years of age and over 2 teaspoonfuls every 4 hours children 6 years to under 12 years of age 1 teaspoonful every 4 hours children 2 years to under 6 years of age 1/2 teaspoonful every 4 hours under 2 years of age ask a doctor", "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.", "Other information": "• store at room temperature 15º - 30ºC (59º - 86ºF) • protect from freezing. • protect from light. • Each teaspoon (5 mL) contains: sodium 2 mg. • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING", "Inactive ingredients": "citric acid, FD&C Red #40, flavors, glucose, glycerin, high fructose corn syrup, menthol, saccharin sodium, sodium benzoate, water", "Active ingredients (in each 5 mL)(one teaspoonful)": "Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg"}