FDA.reportPublic FDA data

Chlorpheniramine Maleate

Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises
Effective date
2017-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:32

Label at a glance#

ProductChlorpheniramine Maleate
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure11 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy nose or throat itchy watery eyes sneezing

Dosage and administration

adults and children 12 years of age and older            one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours children 6 to under 12 years of age 1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours children under 6 years of age consult a physician

Storage and handling

Tamper Evident: Do not Use If Safety Seal Under Cap Is Broken Or Missing store at controlled room temperature 15 o -25 o C (59 o -77 o F) protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • itchy watery eyes
  • sneezing

Ask a doctor before use if you have,

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


adults and children 12 years of age and older           
one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours
children 6 to under 12 years of age
1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
children under 6 years of age
consult a physician

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not Use If Safety Seal Under Cap Is Broken Or Missing
  • store at controlled room temperature 15 o-25 oC (59 o-77 oF)
  • protect from excessive moisture

Questions:

OTC - QUESTIONS SECTION

To Report Adverse Drug Events Call 800-687-0176.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label
image of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN1
1363309chlorpheniramine maleate 4 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016103346112GTIN-13: 0016103346112
EAN-13: 0016103346112
GTIN-12: 016103346112
UPC-A: 016103346112
GTIN storage (14 digits): 00016103346112		SDA Chlorpheniramine Maleate 4 mg 1000 CT. Label.jpg
Data codeCode 128016103346112SDA Chlorpheniramine Maleate 4 mg 1000 CT. Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-097-072022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097
67046-097-142022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097
67046-097-152022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097
67046-097-212022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097
67046-097-282022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097
67046-097-302022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097
67046-097-602022-01-28C16284748780-1d6a99b39-68b9-a426-e053-dadaa90af4c2Drug Facts 097

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-097-07Chlorpheniramine Maleate7 in 1 BLISTER PACKTABLET71
67046-097-14Chlorpheniramine Maleate14 in 1 BLISTER PACKTABLET141
67046-097-15Chlorpheniramine Maleate15 in 1 BLISTER PACKTABLET151
67046-097-21Chlorpheniramine Maleate21 in 1 BLISTER PACKTABLET211
67046-097-28Chlorpheniramine Maleate28 in 1 BLISTER PACKTABLET281
67046-097-30Chlorpheniramine Maleate30 in 1 BLISTER PACKTABLET301
67046-097-60Chlorpheniramine Maleate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-097CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 7 package rows20170919_598dd7ef-5048-c6dd-e053-2991aa0a87a2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67046-09767046-097-14, 67046-097-07, 67046-097-15, 67046-097-21, 67046-097-28, 67046-097-30, 67046-097-60
66424-034

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB

Source Document#

Source XML · Source PDF

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
598dd7ef-5049-c6dd-e053-2991aa0a87a2598dd7ef-5048-c6dd-e053-2991aa0a87a22017-09-19WarningsExact identifier
spl id: 598dd7ef-5049-c6dd-e053-2991aa0a87a2
spl set id: 598dd7ef-5048-c6dd-e053-2991aa0a87a2

Reported adverse events (FAERS/openFDA)#

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