major pharmaceuticals robafen®

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (20 mg) guaifenesin (200 mg)

Inactive Ingredients

aspartame benzoic acid glycerin polyethylene glycol water menthol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2018-12-19

Medication Information

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

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

Other Information

•
Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL
•
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

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.

Ndc 17856 6756 02

Ndc 17856 6759 01

Questions Or Comments?

1-800-616-2471

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N/E 16TH PLACE

MIAMI, FL 33179

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

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

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

Other Information (Other information)

•
Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL
•
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

Purposes

Cough suppressant

Expectorant

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.

Ndc 17856 6756 02 (NDC 17856-6756-02)

Ndc 17856 6759 01 (NDC 17856-6759-01)

Questions Or Comments? (Questions or comments?)

1-800-616-2471

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N/E 16TH PLACE

MIAMI, FL 33179

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).

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.", "Other information": "• Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL • store at 20-25°C (68-77°F). Do not refrigerate.", "Inactive ingredients": "aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water", "Questions or comments?": "1-800-616-2471 DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. 20101 N/E 16TH PLACE MIAMI, FL 33179", "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"}