DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI

FDA Drug Profile — HISTEX-DM New Formulation

Drug Details

Generic Name
DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI
Brand Names
HISTEX-DM New Formulation
Application Number
M012
Sponsor
Allegis Pharmaceuticals, LLC
NDC Codes
1
Dosage Forms
SYRUP
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Warnings

Warnings Do not exceed recommended dosage. Do not use this product 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 giving this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.