NDC | 43378-115-08 |
Set ID | 38ace253-dea2-4b0a-8746-9f282c871368 |
Category | HUMAN OTC DRUG LABEL |
Packager | CodaDose Inc. |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- OTC - ACTIVE INGREDIENT
Chlorpheniramine Maleate 0.266 mg/1mL: antihistamine; Codeine Phosphate 1 mg/1mL: cough suppressant; Pseudoephedrine Hydrochloride 4 mg/1mL: decongestant
Close - 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; 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
Close - 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; if taking a monoamine oxidase inhibitor (MAOI)
Close - 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.
Close - 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.
Close - 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
Close - 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.
Close - 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: 7.5 mL
Other information store at controlled room temperature 20°-25°C (68°-77°F).
Close -
- INACTIVE INGREDIENT
citric acid, FD&C blue#1, galloquinate, glycerin, grape flavor, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, xanthan gum
Close - OTC – QUESTIONS SECTION
- 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 DAC 60
chlorpheniramine maleate, codeine phosphate and pseudoephedrine hydrochloride suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43378-115 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1.995 mg in 7.5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE 7.5 mg in 7.5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 7.5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 blue Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43378-115-08 236 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2040 Labeler - CodaDose Inc. (831355115) Registrant - Gorbec Pharmaceutical Services Inc. (791919678) Establishment Name Address ID/FEI Business Operations Gorbec Pharmaceutical Services Inc. 791919678 manufacture