ZODRYL DAC 60- chlorpheniramine maleate, codeine phosphate and pseudoephedrine hydrochloride suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

CodaDose Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants; the intensity of coughing; the impulse to cough to help you go to sleep; temporarily relieves nasal congestion due to a cold; temporarily restores freer breathing through the nose; temporarily decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies Warnings in children who have chronic pulmonary disease, shortness of breath, or who are taking other drugs unless directed by a doctor; for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor; if taking a monoamine oxidase inhibitor (MAOI) cough 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

ZODRYL DAC 60 - CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE AND
PSEUDOEPHEDRINE
HYDROCHLORIDE SUSPENSION
CODADOSE 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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ZODRYL DAC 60 – CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, AND
PSEUDOEPHEDRINE
HYDROCHLORIDE SUSPENSION
OTC - ACTIVE INGREDIENT
Chlorpheniramine Maleate 0.266 mg/1mL: antihistamine; Codeine
Phosphate 1 mg/1mL: cough
suppressant; Pseudoephedrine Hydrochloride 4 mg/1mL: decongestant
PURPOSE
Temporarily relieves: cough due to minor throat and bronchial
irritation as may occur with the common
cold or inhaled irritants; the intensity of coughing; the impulse to
cough to help you go to sleep;
temporarily relieves nasal congestion due to a cold; temporarily
restores freer breathing through the
nose; temporarily decreases runny nose and reduces sneezing, itching
of the nose or throat, and itchy,
watery eyes due to hay fever or other upper respiratory allergies
Warnings
OTC - DO NOT USE
in children who have chronic pulmonary disease, shortness of breath,
or who are taking other drugs
unless directed by a doctor; for persistent or chronic cough such as
occurs with asthma or if cough is
accompanied by excessive phlegm (mucus) unless directed by a doctor;
if taking a monoamine oxidase
inhibitor (MAOI)
OTC - ASK DOCTOR
if your child has glaucoma, a breathing problem such as emphysema or
chronic bronchitis, heart
disease, high blood pressure, thyroid disease, diabetes.
OTC - ASK DOCTOR/PHARMACIST SECTION
if you or your child are taking sedatives or tranquilizers; if you or
your child are taking prescription
MAOI (certain drugs for depression, psychiatric, or emotional
conditions), or for 2 weeks after
stopping the MAOI drug.
OTC - WHEN USING THIS PRODUCT
do not exceed recommended dosage; may cause or aggravate constipation;
may cause excitability in
children; may cause drowsiness; alcohol, s