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

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Zodryl DEC 25

CodaDose, Inc.
Gorbec Pharmaceutical Services Inc.

ZODRYL DEC 25 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension




FULL PRESCRIBING INFORMATION

Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 5 mg/1mL: decongestant

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; helps loosen phlegm (mucus) and thin bronchial passageways of bothersome mucus and makes coughs more productive

Warnings

in children who have chronic pulmonary disease, shortness of breath, or 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)

if your child has glaucoma, a breathing problem such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes.

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.

do not exceed recommended dosage; may cause or aggravate constipation; if nervousness, dizziness, or sleepiness occur, discontinue use and consult 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.

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).

INACTIVE INGREDIENT

Bittermask, citric acid, FD& C blue #1, 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 DEC 25
Figure 1.  Primary Label- Front Page Figure 2.  Primary Label – Second Page Figure 3.  Primary Label – Last Page

Zodryl DEC 25

codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43378-120
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg
CODEINE PHOSPHATE CODEINE ANHYDROUS 3 mg
Guaifenesin GUAIFENESIN 60 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
TANNIC ACID
GLYCERIN
magnesium aluminum silicate
METHYLPARABEN
water
SODIUM CITRATE
Sucralose
XANTHAN GUM

Product Characteristics

Color
purple

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43378-120-04 118 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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