Zodryl DEC 25

Dosage form: suspension
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 15mg in 3mL, CODEINE PHOSPHATE 3mg in 3mL, GUAIFENESIN 60mg in 3mL
Labeler: CodaDose, Inc.
NDC Code: 43378-120

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 25 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

OTC - ACTIVE INGREDIENT

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

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 25 
codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43378-120
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 3 mL
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE3 mg  in 3 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN60 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43378-120-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/24/2009
Labeler - CodaDose, Inc. (831355115)
Registrant - Gorbec Pharmaceutical Services Inc. (791919678)
Establishment
NameAddressID/FEIOperations
Gorbec Pharmaceutical Services Inc.791919678manufacture

Revised: 08/2009
 
CodaDose, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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