COLD AND ALLERGY CHILDRENS- brompheniramine maleate, phenylephrine hcl liquid

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
17-05-2023

Wirkstoff:

BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Verfügbar ab:

P & L Development, LLC

INN (Internationale Bezeichnung):

BROMPHENIRAMINE MALEATE

Zusammensetzung:

BROMPHENIRAMINE MALEATE 2 mg in 10 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Antihistamine Nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves these symptoms due to hay fever (allergic rhinitis) runny nose itchy, watery eyes sneezing itching of the nose or throat - runny nose - itchy, watery eyes - sneezing - itching of the nose or throat - temporarily restores freer breathing through the nose  ​​​

Berechtigungsstatus:

OTC monograph final

Fachinformation

                                COLD AND ALLERGY CHILDRENS- BROMPHENIRAMINE MALEATE, PHENYLEPHRINE
HCL LIQUID
P & L DEVELOPMENT, 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._
----------
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 10 ML)
Brompheniramine maleate 2 mg
Phenylephrine HCI 5 mg
PURPOSES
Antihistamine
Nasal decongestant
USES
temporarily relieves nasal congestion due to the common cold, hay
fever or other
upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic
rhinitis)
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat
temporarily restores freer breathing through the nose
​​​
WARNINGS
DO NOT USE
to sedate a child or to make a child sleepy
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
glaucoma
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
STOP USE AND ASK A DOCTOR IF
nervousness, dizziness or sleeplessness occur
symptoms do not get better 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 c
                                
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