Zodryl AC 25 description, usages, side effects, indications, overdosage, supplying and lots more!

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Zodryl AC 25

CodaDose, Inc.
Gorbec Pharmaceutical Services Inc.

ZODRYL AC 25 – chlorpheniramine maleate and codeine phosphate suspension




FULL PRESCRIBING INFORMATION

Chlorpheniramine maleate 0.333mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant

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

before use if you or your child has glaucoma; a breathing problem such as emphysema or chronic bronchitis

if you or your child are taking sedatives or tranquilizers

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

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.

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 dispenser

  • Do not take more than 4 doses in 24 hours or as directed by a doctor

Children 2 to under 6 years of age:  ask a doctor

Other information store at controlled room temperature 20°-25°C (68°-77°F).

Citric acid, FD&C red #40, galloquinate, glycerin, grape flavor, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, xanthan gum

Call 1-866-574-8861 24 hours a day, 7 days a week.

Zodryl AC 25
Figure 1.  Primary Label- Front Page Figure 2. Primary Label – Second Page Figure 3. Primary Label – Last Page

Zodryl AC 25

Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43378-100
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 0.999 mg
CODEINE PHOSPHATE CODEINE ANHYDROUS 3 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
TANNIC ACID
GLYCERIN
magnesium aluminum silicate
METHYLPARABEN
water
SODIUM CITRATE
Sucralose
XANTHAN GUM

Product Characteristics

Color
red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43378-100-04 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-08-24


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