Rugby Laboratories Cough Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (200 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Propylene Glycol Water Sodium Benzoate Menthol, Unspecified Form Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-08-22

Medication Information

Purpose

Cough suppressant Expectorant

How Supplied

Product: 50090-4287

NDC: 50090-4287-0 118 mL in a BOTTLE / 1 in a CARTON

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 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

Purposes

Cough suppressant

Expectorant

Directions

•
do not take more than 6 doses in any 24-hour period
•
measure only with dosing cup provided
•
keep dosing cup with product
•
mL = milliliter
•
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL every 4 hours
children under 12 years	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.

Other Information

•
each 10 mL contains: sodium 6 mg
•
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions Or Comments?

1-800-645-2158

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).

Dextromethorphan Hbr, Guaifenesin

Active Ingredients (in Each 10 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

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

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

Purposes

Cough suppressant

Expectorant

Directions

•
do not take more than 6 doses in any 24-hour period
•
measure only with dosing cup provided
•
keep dosing cup with product
•
mL = milliliter
•
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL every 4 hours
children under 12 years	do not 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.

How Supplied (HOW SUPPLIED)

Product: 50090-4287

NDC: 50090-4287-0 118 mL in a BOTTLE / 1 in a CARTON

Other Information (Other information)

•
each 10 mL contains: sodium 6 mg
•
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions Or Comments? (Questions or comments?)

1-800-645-2158

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

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).

Dextromethorphan Hbr, Guaifenesin (Dextromethorphan HBr, Guaifenesin)

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

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

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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", "Purposes": "Cough suppressant Expectorant", "Directions": "• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years 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.", "HOW SUPPLIED": "Product: 50090-4287 NDC: 50090-4287-0 118 mL in a BOTTLE / 1 in a CARTON", "Other information": "• each 10 mL contains: sodium 6 mg • store at 20-25°C (68-77°F). Do not refrigerate.", "Inactive ingredients": "anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose", "Questions or comments?": "1-800-645-2158", "Stop use and ask a doctor if": "cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).", "Active ingredients (in each 10 mL)": "Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg", "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"}