ED-A-HIST DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

EDWARDS PHARMACEUTICALS, INC.

INN (International Name):

CHLORPHENIRAMINE MALEATE

Composition:

CHLORPHENIRAMINE MALEATE 4 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes - cough due to minor throat and bronchial irritation - nasal congestion - reduces swelling of nasal passages

Authorization status:

unapproved drug other

Summary of Product characteristics

ED-A-HIST DM- CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE,
AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
EDWARDS PHARMACEUTICALS, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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ED-A-HIST DM TABLETS
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH TABLET)_
_PURPOSE_
Chlorpheniramine Maleate 4 mg
Antihistamine
Dextromethorphan HBr 10 mg
Antitussive
Phenylephrine HCl 10 mg
Nasal
Decongestant
USES
temporarily relieves these symptoms due to the common cold, hay fever
(allergic
rhinitis) or other respiratory allergies:
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
cough due to minor throat and bronchial irritation
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
DO NOT USE THIS PRODUCT, UNLESS DIRECTED BY A DOCTOR, IF YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
glaucoma
a persistent or chronic cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland
DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING SEDATIVES OR TRANQUILIZERS,
WITHOUT
FIRST CONSULTING YOUR DOCTOR.
WHEN USING THIS PRODUCT
excitability may occur, especially in children
may cause marked drowsiness
sedatives and tranquilizers may increase 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 p