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Zodryl Dec 60

Generic Name: pseudoephedrine hydrochloride, codeine phosphate and guaifenesin
Dosage Form: oral suspension

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.

Zodryl Dec 60 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

OTC - ACTIVE INGREDIENT

Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 4 mg/1mL: decongestant

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

Warnings

OTC - DO NOT USE

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)

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; if nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor

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 dispenser

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

Children 6 to under 12 years of age:  7.5mL

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

OTC – QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1.  Primary Label- Front Page

Figure 2. Primary Label – Second Page

Figure 3. Primary Label – Last Page

Zodryl Dec 60 
codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43378-125
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 7.5 mL
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 7.5 mg  in 7.5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 150 mg  in 7.5 mL
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 Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:43378-125-08 236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/24/2009
Labeler - CodaDose, Inc. (831355115)
Registrant - Gorbec Pharmaceutical Services Inc. (791919678)
Establishment
Name Address ID/FEI Operations
Gorbec Pharmaceutical Services Inc. 791919678 manufacture
Revised: 08/2009
 
CodaDose, Inc.



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