ZODRYL AC 25- chlorpheniramine maleate and codeine phosphate suspension

Drug Details [pdf]

OTC - ACTIVE INGREDIENT

Chlorpheniramine maleate 0.333mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant
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 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
OTC - DO NOT USE

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
OTC - ASK DOCTOR

before use if you or your child has glaucoma; a breathing problem such as emphysema or chronic bronchitis
OTC - ASK DOCTOR/PHARMACIST SECTION

if you or your child are taking sedatives or tranquilizers
OTC - WHEN USING THIS PRODUCT

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
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

Citric acid, 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 AC 25
chlorpheniramine maleate and codeine phosphate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43378-100
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	0.999 mg in 3 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520)	CODEINE PHOSPHATE	3 mg in 3 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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	red	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/24/2009

Labeler - CodaDose, Inc. (831355115)

Registrant - Gorbec Pharmaceutical Services Inc. (791919678)

Name	Address	ID/FEI	Business Operations
Establishment
Gorbec Pharmaceutical Services Inc.		791919678	manufacture

ZODRYL AC 25- chlorpheniramine maleate and codeine phosphate suspension

Zodryl AC 25 by

Drug Labeling and Warnings

Drug Details [pdf]