BROVEX PSB- pseudoephedrine hydrochloride and brompheniramine maleate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F), Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)

Available from:

MCR American Pharmaceuticals, Inc.

INN (International Name):

Pseudoephedrine Hydrochloride

Composition:

Pseudoephedrine Hydrochloride 20 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

BROVEX PSB- PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE
LIQUID
MCR AMERICAN PHARMACEUTICALS, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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BRŌVEX PSB
LIQUID
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH 5 ML TEASPOONFUL)_
_PURPOSE_
Brompheniramine Maleate 4
mg
Antihistamine
Pseudoephedrine HCl 20 mg
Decongestant
US ES
temporarily relieves these symptoms due to the common cold, hay fever
(allergic rhinitis) or other
respiratory allergies:
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion
reduces swelling of nasal passages
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 taking this product
ASK A DOCTOR BEFORE USE IF YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
high blood pressure
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland
DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING SEDATIVES OR TRANQUILIZERS,
WITHOUT FIRST CONSULTING YOUR
DOCTOR.
WHEN USING THIS PRODUCT
excitability may occur, especially in children
™
may cause drowsiness
sedatives and tranquilizers may increase drowsiness
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
If symptoms do not improve within 7 days or are accompanied by fever,
consult a doctor
new symptoms occur
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose,