POLYTUSSIN DM- dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Poly Pharmaceuticals, Inc.

INN (International Name):

DEXCHLORPHENIRAMINE MALEATE

Composition:

DEXCHLORPHENIRAMINE MALEATE 1 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants - 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 - sneezing - itching of the nose or throat - itchy, watery eyes - Temporarily restores freer breathing through the nose Stop use and ask a doctor if < cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. < symptoms do not improve within 7 days or are accompanied by fever < nervousness, dizziness, or sleeplessness occur Antihistamine Cough Suppressant Nasal Decongestant

Authorization status:

OTC monograph final

Summary of Product characteristics

POLYTUSSIN DM- DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR,
PHENYLEPHRINE
HCL SYRUP
POLY 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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POLYTUSSIN DM
Active ingredients
(in each 5 mL teaspoonful)
Dexchlorpheniramine Maleate 1 mg .............Antihistamine
Dextromethorphan HBr 10 mg ........... Cough Suppressant
Phenylephrine HCl 5 mg ....................Nasal Decongestant
Ask a doctor or pharmacist before use if you are taking sedatives or
tranquilizers.
Uses
temporarily relieves cough due to minor throat and bronchial
irritation occurring with a cold or
inhaled irritants
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
sneezing
itching of the nose or throat
itchy, watery eyes
Temporarily restores freer breathing through the nose
Warnings
Do not use 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
thyroid disease
diabetes
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlarged prostrate gland
persistent or chronic cough such as occurs with smoking, asthma or
emphysema
cough accompanied by excessive phlegm (mucus)
When using this product < do not exceed recommended dosage < marked
drowsiness may occur <
alcohol, sedatives, and tranquilizers may increase the drowsiness
effect < avoid alcoholic beverages <
use caution when driving a motor vehicle or operating machinery <
excitabili