Zodryl DAC 40
- Manufacturer
- CodaDose Inc. | Gorbec Pharmaceutical Services Inc.
- Effective date
- 2009-09-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:55:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT
Chlorpheniramine Maleate 0.222 mg/1mL: antihistamine; Codeine Phosphate 1 mg/1mL: cough suppressant; 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; 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; 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; 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 blue#1, 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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 995065 | codeine phosphate 1 MG / chlorpheniramine maleate 0.222 MG / pseudoephedrine HCl 3.33 MG in 1 mL Oral Suspension | PSN | 1 |
| 995067 | Zodryl DAC 40, 1 MG / 0.222 MG / 33.3 MG in 1 mL Oral Suspension | PSN | 1 |
| 995067 | chlorpheniramine maleate 0.222 MG/ML / codeine phosphate 1 MG/ML / pseudoephedrine hydrochloride 3.33 MG/ML Oral Suspension [Zodryl DAC] | SBD | 1 |
| 995065 | chlorpheniramine maleate 0.222 MG/ML / codeine phosphate 1 MG/ML / pseudoephedrine hydrochloride 3.33 MG/ML Oral Suspension | SCD | 1 |
| 995065 | chlorpheniramine maleate 0.222 MG / codeine phosphate 1 MG / pseudoephedrine HCl 3.33 MG per 1 ML Oral Suspension | SY | 1 |
| 995067 | Zodryl DAC 40 (chlorpheniramine maleate 0.222 MG / codeine phosphate 1 MG / pseudoephedrine HCl 33.3 MG) per 1 ML Oral Suspension | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43378-113-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb20-621f-e053-dbdaa90a74ad | ZODRYL DAC 40 – chlorpheniramine maleate, codeine phosphate, and pseudoephedrine hydrochloride suspension |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43378-113-04 | Zodryl DAC 40 | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43378-113-04 | ML - Milliliter | 43378-113 | f58776b0-36e3-457c-a3ac-cdd5fdc6416b | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Zodryl DAC 40
- chlorpheniramine maleate, codeine phosphate and pseudoephedrine hydrochloride
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- CODEINE PHOSPHATE
- CODEINE
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- TANNIC ACID
- GLYCERIN
- MAGNESIUM ALUMINUM SILICATE
- METHYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43378-113 | 43378-113-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| TANNIC ACID | 28F9E0DJY6 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| cee39940-7034-4066-a1c8-6d38f3d60693 | ad75c676-6135-4803-93d6-5c6ea16a2c9a | 2009-09-22 | cee39940-7034-4066-a1c8-6d38f3d60693 ad75c676-6135-4803-93d6-5c6ea16a2c9a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


