FDA.reportPublic FDA data

Major 44-194

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2020-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:06:41

Label at a glance#

ProductAllergy
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

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

Dosage and administration

• take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use

Storage and handling

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • protect from excessive moisture • see end flap for expiration date and lot number

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

• take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use

Other Label Information

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • 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 ingredients

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

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR® NDC 68788-6951 4 Hour Allergy Tablets Chlorpheniramine Maleate 4 mg Antihistamine Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat Actual Size 24 Tablets TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0419ML19412 Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 Rev. 10/19 M-17 Re-order No. 700790 Repackaged By: Preferred Pharmaceuticals Inc. Major 44-194

Label Images#

major-44-194-1
major-44-194-1

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
68788-6951-22022-01-28C16284748780-1d6a99b39-7002-a426-e053-dadaa90af4c2Major 44-194

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-6951-2Allergy12 in 1 BLISTER PACKTABLET123
68788-6951-2Allergy2 in 1 CARTONTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6951ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC, 2 package rows20200418_2dbd56d5-2bb5-4697-b7cb-e4c154321997.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

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-695168788-6951-2
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
ANHYDROUS LACTOSE3SY5LH9PMKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT

Complete SPL Sections#

Complete SPL sections page 1 of 1 · 9 matching rows.

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, watery eyes • sneezing • itching of the nose or throat

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use

Other information

STORAGE AND HANDLING SECTION

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • 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 ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR® NDC 68788-6951 4 Hour Allergy Tablets Chlorpheniramine Maleate 4 mg Antihistamine Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat Actual Size 24 Tablets TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0419ML19412 Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 Rev. 10/19 M-17 Re-order No. 700790 Repackaged By: Preferred Pharmaceuticals Inc. Major 44-194

Source Document#

Source XML

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
cd332660-110b-4da8-8c69-4fcb5ef778102dbd56d5-2bb5-4697-b7cb-e4c1543219972020-04-17WarningsExact identifier
spl id: cd332660-110b-4da8-8c69-4fcb5ef77810
spl set id: 2dbd56d5-2bb5-4697-b7cb-e4c154321997

Reported adverse events (FAERS/openFDA)#

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