Zodryl AC 50

Dosage form: suspension
Ingredients: CHLORPHENIRAMINE MALEATE 2mg in 5mL, CODEINE PHOSPHATE 5mg in 5mL
Labeler: CodaDose, Inc.
NDC Code: 43378-104

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 AC 50 – chlorpheniramine maleate and codeine phosphate suspension

OTC - ACTIVE INGREDIENT

Chlorpheniramine maleate 0.400 mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant

OTC - 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

if you or your child are taking sedatives or tranquilizers

OTC - WHEN USING

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

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 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:  5mL

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

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 AC 50 
chlorpheniramine maleate and codeine phosphate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43378-104
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
TANNIC ACID 
GLYCERIN 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
WATER 
SODIUM CITRATE 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
ColorredScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43378-104-08236 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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