ZODRYL AC 35- chlorpheniramine maleate and codeine phosphate 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)

Available from:

CodaDose, Inc.

INN (International Name):

CHLORPHENIRAMINE MALEATE

Composition:

CHLORPHENIRAMINE MALEATE 0.999 mg in 4.5 mL

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 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 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 AC 35 - CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE
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 AC 35 – CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE
SUSPENSION
OTC - ACTIVE INGREDIENT
Chlorpheniramine maleate 0.250 mg/1mL: antihistamine; Codeine
phosphate 1 mg/1mL: cough
suppressant
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 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
OTC - ASK DOCTOR
before use if you or your child has glaucoma; a breathing problem such
as emphysema or chronic
bronchitis
OTC - ASK DOCTOR/PHARMACIST SECTION
if you or your child are taking sedatives or tranquilizers
OTC - WHEN USING THIS PRODUCT
do not exceed recommended dosage; may cause or aggravate constipation;
may cause excitability in
children; may cause drowsiness; alcohol, sedatives, and tranquilizers
may increase the drowsiness
effect
OTC - STOP USE AND ASK A DOCTOR IF
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.
OTC - KEEP THESE AND ALL DRUGS OUT OF REACH OF CHILDREN
In case of overdose, seek professional assistance for contact a Poison
Control Center immediately.
Directions:
Take every 4-6 hours
Use only with enclosed calibrated oral dis