HISTEX-DM- dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)

Available from:

Allegis Pharmaceuticals, LLC

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: - cough due to minor throat or bronchial irritation - 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

HISTEX-DM- DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,
AND TRIPROLIDINE HYDROCHLORIDE SYRUP
ALLEGIS PHARMACEUTICALS, LLC
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HISTEX™-DM SYRUP
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_5 ML TEASPOONFUL)_
_PURPOSE_
Dextromethorphan HBr 20 mg
Cough
Suppressant
Phenylephrine HCl 10 mg
Decongestant
Triprolidine HCl 2.5 mg
Antihistamine
USES
temporarily relieves these symptoms due to common cold, hay fever
(allergic rhinitis) or
other upper respiratory allergies:
cough due to minor throat or bronchial irritation
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 giving this
product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a persistent or chronic cough such occurs with smoking, asthma,
chronic
bronchitits, or emphysema
a cough that occurs with too much phlegm (mucus)
a cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland
ASK A DOCTOR BEFORE USE IF YOU ARE TAKING SEDATIVES OR TRANQUILIZERS
WHEN USING THIS PRODUCT
excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase the drowsiness
effect
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
cough or nasal congestion persists for more than 1 week, tends to
recur or is
accompanied by a fever, rash or persistent headache. These could be
signs of a
serious condition.
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