FDA.reportPublic FDA data

CHLORPHENIRAMINE MALEATE

Manufacturer
DIRECT RX
Effective date
2015-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:44:18

Label at a glance#

ProductCHLORPHENIRAMINE MALEATE
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Do not use

    to make a child sleepy.

    Ask a doctor before use if you have
    • a breathing problem such as emphysema or chronic bronchitis  
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

  • adults and children
    12 years  of age
    and over    		1 tablet every 4 to 6
    hours. Do not take more than 6 tablets in 24 hours.
    children 6 to under 12 years of  age

    		1/2 tablet (break tablet in half) every 4 to 6 hours.
    Do not exceed 3 whole tablets in 24 hours.
    children under 6 years of agedo not use this product in children under 6 years of age

INFORMATION FOR PATIENTS SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive moisture
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

  • corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

OTC - QUESTIONS SECTION

(800) 616-2471

WARNINGS SECTION


Do not use

to make a child sleepy.

Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN3
1363309chlorpheniramine maleate 4 MG Oral TabletSCD3

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
61919-402-302020-01-31C16284748780-19d75b9d0-abbe-f424-e053-dadaa90a57ceCHLORPHENIRAMINE MALEATE
61919-402-712020-01-31C16284748780-19d75b9d0-abbe-f424-e053-dadaa90a57ceCHLORPHENIRAMINE MALEATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-402-30CHLORPHENIRAMINE MALEATE30 in 1 BOTTLETABLET303
61919-402-71CHLORPHENIRAMINE MALEATE1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-402CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]3Legacy NDC, 2 package rows20151208_4c59bf7c-eb93-4792-9326-0076e7c55c39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-402-30EA - Each61919-402d52f496e-b613-4dad-971e-55ab7ea3df0b12018-09-05
61919-402-71EA - Each61919-4022afa47bc-a7a3-4628-8a74-fda76abece1712015-04-03
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
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-40261919-402-71, 61919-402-30
0904-0012

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 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
2badb011-7f09-440c-9aea-59ad6004cfe44c59bf7c-eb93-4792-9326-0076e7c55c392015-12-08WarningsExact identifier
spl id: 2badb011-7f09-440c-9aea-59ad6004cfe4
spl set id: 4c59bf7c-eb93-4792-9326-0076e7c55c39

Reported adverse events (FAERS/openFDA)#

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