ZODRYL DEC 40- codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

Zodryl DEC 40 by

Drug Labeling and Warnings

Zodryl DEC 40 by is a Otc medication manufactured, distributed, or labeled by CodaDose, Inc., Gorbec Pharmaceutical Services Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT

Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 3.333 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

INGREDIENTS AND APPEARANCE

ZODRYL DEC 40 
codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43378-123
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	14.998 mg  in 4.5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520)	CODEINE PHOSPHATE	4.5 mg  in 4.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	90 mg  in 4.5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TANNIC ACID (UNII: 28F9E0DJY6)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43378-123-04	118 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	Business Operations
Gorbec Pharmaceutical Services Inc.		791919678	manufacture