Sorbugen®

Sorbugen®
SPL v7
SPL
SPL Set ID a8f2a2d7-0360-45a8-9635-c852f4a7d7ba
Route
ORAL
Published
Effective Date 2025-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Guaifenesin (150 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Propylene Glycol Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-08

Description

Dextromethorphan HBr, 15 mg Guaifenesin (Glyceryl Guaiacolate), 150mg

Purpose

Antitussive Expectorant


Medication Information

Purpose

Antitussive Expectorant

Description

Dextromethorphan HBr, 15 mg Guaifenesin (Glyceryl Guaiacolate), 150mg

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 rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive
Section 42229-5

Contains the same active ingredients as Sorbutuss® NR*

Dextromethorphan HBr

ANTITUSSIVE

Guaifenesin (Glyceryl Guaiacolate)

EXPECTORANT

Antihistamine & Decongestant Free

​SUGAR, DYE & ALCOHOL FREE

GRAPE FLAVOR

KramerNovis

Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis,

San Juan, PR 00917.

www.kramernovis.com



*Sorbutuss® NR is a registered trademark of Teral, Inc. 

This product is not manufactured, distributed or marketed by Teral, Inc.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purposes

Antitussive

Expectorant

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.

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.

When using this product, do not use more than directed.

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.

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

Packaging

Directions

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

 • mL = milliliter

 • tsp = teaspoon

 age  dose
 Adults and children 12 years

of age and over
 2 teaspoonfuls (10 mL)

every 4 hours
 Children under 12 years of age  Consult a physician

Drug Facts

Other Information
  • Tamper evident feature: Do not use if printed security seal is torn, broken or missing.
  • Store at controlled room temperature 15-30°C (59-86°F).
  • Avoid excessive heat or humidity.
Active Ingredients

Dextromethorphan HBr, 15 mg

Guaifenesin (Glyceryl Guaiacolate), 150mg

Inactive Ingredients

Citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

Questions Or Comments?

1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST


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 rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive
Section 42229-5 (42229-5)

Contains the same active ingredients as Sorbutuss® NR*

Dextromethorphan HBr

ANTITUSSIVE

Guaifenesin (Glyceryl Guaiacolate)

EXPECTORANT

Antihistamine & Decongestant Free

​SUGAR, DYE & ALCOHOL FREE

GRAPE FLAVOR

KramerNovis

Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis,

San Juan, PR 00917.

www.kramernovis.com



*Sorbutuss® NR is a registered trademark of Teral, Inc. 

This product is not manufactured, distributed or marketed by Teral, Inc.

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.

Purposes

Antitussive

Expectorant

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.

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.

When using this product, do not use more than directed.

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.

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

Packaging

Directions

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

 • mL = milliliter

 • tsp = teaspoon

 age  dose
 Adults and children 12 years

of age and over
 2 teaspoonfuls (10 mL)

every 4 hours
 Children under 12 years of age  Consult a physician

Drug Facts

Other Information (Other information)
  • Tamper evident feature: Do not use if printed security seal is torn, broken or missing.
  • Store at controlled room temperature 15-30°C (59-86°F).
  • Avoid excessive heat or humidity.
Active Ingredients

Dextromethorphan HBr, 15 mg

Guaifenesin (Glyceryl Guaiacolate), 150mg

Inactive Ingredients

Citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

Questions Or Comments? (Questions or comments?)

1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST


Advanced Ingredient Data


Raw Label Data

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