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

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:

Syntho Pharmaceuticals, Inc.

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:

OTC monograph final

Summary of Product characteristics

ED-A-HIST DM- CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE,
AND PHENYLEPHRINE HYDROCHLORIDE TABLET
SYNTHO 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._
----------
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 sleeple