DALLERGY dexbrompheniramine maleate phenylephrine hydrochloride syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)

Available from:

Laser Pharmaceuticals, LLC

INN (International Name):

DEXBROMPHENIRAMINE MALEATE

Composition:

DEXBROMPHENIRAMINE MALEATE 1 mg in 5 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

DALLERGY- DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
SYRUP
LASER 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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DALLERGY SYRUP IMPROVED FORMULATION
DRUG FACTS
_ACTIVE INGREDIENTS_
_(IN EACH 5 ML TEASPOONFUL)_
Dexbrompheniramine Maleate 1 mg
Phenylephrine Hydrochloride 5 mg
_PURPOSE_
Antihistamine
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
difficulty in urination due to enlargement 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
be careful 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
new symptoms occur
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