Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl

FDA Drug Profile — Desgen Pediatric

Drug Details

Generic Name
Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
Brand Names
Desgen Pediatric
Application Number
M012
Sponsor
Kramer Novis
NDC Codes
1
Dosage Forms
SOLUTION/ DROPS
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

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

Warnings

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