ZODRYL AC 60 – chlorpheniramine maleate and codeine phosphate suspension

Manufacturer
CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.
Effective date
2009-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:35

Label at a glance#

ProductZodryl AC 60
Active ingredientCHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 0.266 mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant

OTC - PURPOSE

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

before use if you or your child has glaucoma; a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

if you or your child are taking sedatives or tranquilizers

OTC - WHEN USING

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:  7.5mL

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

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 1. Primary Label- Front Page
Figure 2. Primary Label – Second Page
Figure 2. Primary Label – Second Page
Figure 3. Primary Label – Last Page
Figure 3. Primary Label – Last Page

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995082codeine phosphate 1 MG / chlorpheniramine maleate 0.267 MG in 1 mL Oral SuspensionPSN1
995084Zodryl AC 60, 1 MG / 0.267 MG in 1 mL Oral SuspensionPSN1
995084chlorpheniramine maleate 0.267 MG/ML / codeine phosphate 1 MG/ML Oral Suspension [Zodryl AC]SBD1
995082chlorpheniramine maleate 0.267 MG/ML / codeine phosphate 1 MG/ML Oral SuspensionSCD1
995082chlorpheniramine maleate 0.267 MG / codeine phosphate 1 MG per 1 ML Oral SuspensionSY1
995084Zodryl AC 60 (chlorpheniramine maleate 0.267 MG / codeine phosphate 1 MG) per 1 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43378-105-082019-10-21C16284748780-1956f9ecf-cf09-621f-e053-dbdaa90a74adZODRYL AC 60 – chlorpheniramine maleate and codeine phosphate suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43378-105-08Zodryl AC 60236 mL in 1 BOTTLE, PLASTICSUSPENSION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43378-105ZODRYL AC 60 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1Legacy NDC, 1 package rows20090904_f7238eb4-5cd2-46ce-86ba-7174f87de3d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43378-105-08ML - Milliliter43378-1057e72ea6c-c4da-4651-84e6-e198f0a907bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN61
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
CODEINEACTIVE MOIETYQ830PW75201
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY61
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43378-10543378-105-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 311 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / SUBLINGUAL12 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii candidate
61 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / RESPIRATORY (INHALATION)5 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCOINTMENT / VAGINAL231 mgExact identifier — unii candidate
17 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
80883522-1b50-4ba4-8375-787feaa941cbf7238eb4-5cd2-46ce-86ba-7174f87de3d62009-08-24Exact identifier
spl id: 80883522-1b50-4ba4-8375-787feaa941cb
spl set id: f7238eb4-5cd2-46ce-86ba-7174f87de3d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.