pseudoephedrine hydrochloride

FDA Drug Profile — nasal decongestant, Pseudoephedrine Hydrochloride, Pseudoephedrine hydrochloride, Zephrex D, equate sinus 12 hour

pseudoephedrine hydrochloride is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including nasal decongestant, Pseudoephedrine Hydrochloride, Pseudoephedrine hydrochloride. Available dosage forms: tablet, film coated, extended release, tablet, extended release, capsule, gelatin coated.

Drug Details

Generic Name
pseudoephedrine hydrochloride
Brand Names
nasal decongestant, Pseudoephedrine Hydrochloride, Pseudoephedrine hydrochloride, Zephrex D, equate sinus 12 hour
Application Number
ANDA075153
Sponsor
Meijer Distribution Inc
NDC Codes
7
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients
PSEUDOEPHEDRINE HYDROCHLORIDE

Indications and Usage

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

Warnings

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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) 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, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).