DEXBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Westminster Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper 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

DEXBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE-
DEXBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE TABLET
WESTMINSTER PHARMACEUTICALS, LLC
_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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DEXBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_TABLET)_
_PURPOSE_
Dexbrompheniramine Maleate 2 mg
Antihistamine
Phenylephrine HCL 10 mg
Nasal
Decongestant
USES
Temporarily relieves these symptoms due to the common cold, hay fever
(allergic
rhinitis) or other upper 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
trouble urinating due to enlargment of the prostate gland
heart disease
high blood pressure
thyroid disease
diabetes
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or
tranquilizers.
WHEN USING THIS PRODUCT
excitability may occur, especially in children
may cause drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness
effect
use caution when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdo