Desgen®

Desgen®
SPL v5
SPL
SPL Set ID 12425c1b-8bdc-446b-83dd-95e05a4d9b8c
Route
ORAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-27

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg

Purpose

Cough Suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg

Uses

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

• temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)

• cough due to minor throat and bronchial irritation as may occur with the common cold

Section 42229-5

Cough Suppressant

Expectorant

Nasal Decongestant

Sugar, Alcohol & Dye Free

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917.

www.kramernovis.com

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

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not use in a child who is 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 child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• heart disease • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma.

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

Stop use and ask a doctor if

• your child gets nervous, dizzy, or sleepless

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

• 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.

Packaging

Directions

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

• repeat every 4 hours.

• measure with the dosage device provided. Do not use with any other device.

Children 2 to under 6 years of age: 1 mL.

Children under 2 years of age: consult a doctor.

Drug Facts

Other Information

Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck.

• Store at controlled room temperature 15-30°C (59-86°F).

• Avoid excessive heat and humidity.

Inactive Ingredients

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

Questions Or Comments? 

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

Active Ingredients (in Each 1 Ml)

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg


Structured Label Content

Uses

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

• temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)

• cough due to minor throat and bronchial irritation as may occur with the common cold

Section 42229-5 (42229-5)

Cough Suppressant

Expectorant

Nasal Decongestant

Sugar, Alcohol & Dye Free

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917.

www.kramernovis.com

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

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not use in a child who is 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 child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• heart disease • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma.

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

Stop use and ask a doctor if

• your child gets nervous, dizzy, or sleepless

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

• 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.

Packaging

Directions

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

• repeat every 4 hours.

• measure with the dosage device provided. Do not use with any other device.

Children 2 to under 6 years of age: 1 mL.

Children under 2 years of age: consult a doctor.

Drug Facts

Other Information (Other information)

Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck.

• Store at controlled room temperature 15-30°C (59-86°F).

• Avoid excessive heat and humidity.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments?  (Questions or comments? )

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

Active Ingredients (in Each 1 Ml) (Active ingredients (in each 1 mL))

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg


Advanced Ingredient Data


Raw Label Data

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