Doxylamine Succinate and Phenylephrine Hydrochloride

FDA Drug Profile — Poly Hist Forte

Drug Details

Generic Name
Doxylamine Succinate and Phenylephrine Hydrochloride
Brand Names
Poly Hist Forte
Application Number
M012
Sponsor
Poly Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves cold symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage

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. to make a child sleepy Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland • a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition. 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.