desgen®
12425c1b-8bdc-446b-83dd-95e05a4d9b8c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Cough Suppressant Expectorant Nasal Decongestant
Description
Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg
Medication Information
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.
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
Purpose
Cough Suppressant Expectorant Nasal Decongestant
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.
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.
Description
Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg
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
Packaging
Drug Facts
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
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.
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
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.
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.
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
Packaging
Drug Facts
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:29.880994 · Updated: 2026-03-14T23:11:00.469021