COUGH AND COLD HBP- chlorpheniramine maleate, dextromethorphan hbr tablet, film 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)

Available from:

L.N.K. International, Inc.

INN (International Name):

CHLORPHENIRAMINE MALEATE

Composition:

CHLORPHENIRAMINE MALEATE 4 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine  Cough suppressant - temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - temporarily relieves runny nose and sneezing due to the common cold

Authorization status:

OTC monograph final

Summary of Product characteristics

COUGH AND COLD HBP- CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN
HBR TABLET, FILM COATED
L.N.K. INTERNATIONAL, INC.
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QUALITY PLUS 44-689
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
_PURPOSE_
Antihistamine
Cough suppressant
_USES_
temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a cold
temporarily relieves runny nose and sneezing due to the common cold
_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
difficulty in urination due to enlargement of the prostate gland
cough that occurs with excessive phlegm (mucus)
glaucoma
a breathing problem or persistent or chronic cough as occurs with
smoking, asthma,
chronic bronchitis, or emphysema
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
persistent cough lasts for more than one week, tends to recur, or is
accompanied by
fever, rash, or persistent headache. These could be signs of a serious
condition.
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 a Poison Control
Center right away.
_DIRECTIONS_
DO NOT EXCEED RECOMMENDED DOSE
adults and children 12 years and over: 1 tablet every 6 hours, not
more than 4
tablets in 24 hours
children under 12 years: do not use
_OTHER INFORMATION_
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR