Desgen®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-10-18

Medication Information

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg Phenylephrine HCl, 5 mg

Uses

• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive

• temporarily relieves nasal congestion due to a cold

Section 42229-5

NEW FORMULA

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

Contains the same active ingredients as Despec® DM *

SUGAR FREE

DYE FREE

ALCOHOL FREE

GRAPE FLAVOR

Kramer Novis

Pharmaceuticals within reach of patients

* Despec® DM is a Registered Trademark of International Ethical Laboratories, Inc. This product is not manufactured, distributed or marketed by International Ethical Laboratories, Inc.

Manufactured in USA with imported ingredients for Kramer Novis.

San Juan, PR 00917

www.kramernovis.com

Section 50565-1

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

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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

• diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • 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

• you get nervous, dizzy, or sleepless

• symptoms do not get better within 7 days or are accompanied by fever

• coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a 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

age	dose
Adults and Children 12 years of age and over	2 teaspoons (10 mL) every 4 hours
Children 6 to under 12 years of age	1 teaspoon (5 mL) every 4 hours
Children under 6 years of age	do not use

Other Information

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

Inactive Ingredients

citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments?

1-787-767-2072

Call weekdays from 8AM to 4PM AST.

Active Ingredients (in Each 5 Ml, 1 Teaspoon)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Phenylephrine HCl, 5 mg

Structured Label Content

Uses

• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive

• temporarily relieves nasal congestion due to a cold

Section 42229-5 (42229-5)

NEW FORMULA

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

Contains the same active ingredients as Despec® DM *

SUGAR FREE

DYE FREE

ALCOHOL FREE

GRAPE FLAVOR

Kramer Novis

Pharmaceuticals within reach of patients

* Despec® DM is a Registered Trademark of International Ethical Laboratories, Inc. This product is not manufactured, distributed or marketed by International Ethical Laboratories, Inc.

Manufactured in USA with imported ingredients for Kramer Novis.

San Juan, PR 00917

www.kramernovis.com

Section 50565-1 (50565-1)

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

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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

• diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • 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

• you get nervous, dizzy, or sleepless

• symptoms do not get better within 7 days or are accompanied by fever

• coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a 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

age	dose
Adults and Children 12 years of age and over	2 teaspoons (10 mL) every 4 hours
Children 6 to under 12 years of age	1 teaspoon (5 mL) every 4 hours
Children under 6 years of age	do not use

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments? (Questions or comments?)

1-787-767-2072

Call weekdays from 8AM to 4PM AST.

Active Ingredients (in Each 5 Ml, 1 Teaspoon) (Active ingredients (in each 5 mL, 1 teaspoon))

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Phenylephrine HCl, 5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive • temporarily relieves nasal congestion due to a cold", "42229-5": "NEW FORMULA COUGH SUPPRESSANT Dextromethorphan HBr EXPECTORANT Guaifenesin NASAL DECONGESTANT Phenylephrine HCl Contains the same active ingredients as Despec® DM * SUGAR FREE DYE FREE ALCOHOL FREE GRAPE FLAVOR Kramer Novis Pharmaceuticals within reach of patients * Despec® DM is a Registered Trademark of International Ethical Laboratories, Inc. This product is not manufactured, distributed or marketed by International Ethical Laboratories, Inc. Manufactured in USA with imported ingredients for Kramer Novis. San Juan, PR 00917 www.kramernovis.com", "50565-1": "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "Purposes": "Cough Suppressant Expectorant Nasal Decongestant", "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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • 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 • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use.", "Directions": "• do not take more than 6 doses in any 24-hour period. • mL = milliliter age dose Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoon (5 mL) every 4 hours Children under 6 years of age do not use", "Other information": "• Tamper evident feature: Do not use if security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.", "Inactive ingredients": "citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.", "Questions or comments?": "1-787-767-2072 Call weekdays from 8AM to 4PM AST.", "Active ingredients (in each 5 mL, 1 teaspoon)": "Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg Phenylephrine HCl, 5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information