FDA.reportPublic FDA data

Chlorpheniramine maleate

Manufacturer
Contract Pharmacy Services-PA
Effective date
2011-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:53

Label at a glance#

ProductChlorpheniramine maleate
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure8 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes

Dosage and administration

take every 4 to 6 hours, not more than 6 doses in 24 hours adults and children 12 years of age and over 1 tablet (4 mg) children 6 to under 12 years of age 1/2 tablet (2 mg) children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • alcohol, sedatives and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful 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

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over1 tablet (4 mg)
children 6 to under 12 years of age1/2 tablet (2 mg)
children 4 to under 6 years of age

do not use unless

directed by a doctor
children under 4 years of agedo not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

1-734-743-6000

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--01/2011--NJW

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister of 30 Tablets
Blister of 30 Tablets

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

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
67046-089-142019-10-29C16284748780-1960f7f55-c69e-8e05-e053-dbdaa90a074aChlorpheniramine Maleate
67046-089-302019-10-29C16284748780-1960f7f55-c69e-8e05-e053-dbdaa90a074aChlorpheniramine Maleate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-089-14Chlorpheniramine maleate14 in 1 BLISTER PACKTABLET141
67046-089-30Chlorpheniramine maleate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-089CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20110111_4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0012-24EA - Each0904-001218a08f0f-7a10-4ded-b696-89ff949ef91a12013-08-02
0904-0012-59EA - Each0904-001241cf3f5e-54c3-4819-9f98-441882d0f47c12013-08-02
0904-0012-61EA - Each0904-001215e3010e-94b9-46dd-883d-957f017c402512013-02-13
0904-0012-80EA - Each0904-001209b8fe40-cac3-4727-b7ff-7579715ad9f312013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67046-08967046-089-14, 67046-089-30
0904-0012

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

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 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
ndc (product): 0904-0012
4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f2011-01-10WarningsExact identifier
spl id: 4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f
spl set id: 4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f

Reported adverse events (FAERS/openFDA)#

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