FDA.reportPublic FDA data

Allergy

Manufacturer
Bryant Ranch Prepack
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
104
Source
full-release
Hydrated at
2026-06-01 01:00:53

Label at a glance#

ProductAllergy
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure10 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from excessive moisture see end flap for expiration date and lot number

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

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

  • a breathing problem such as emphysema or chronic bronchitis  
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

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

  • 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,

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, or as directed by a doctor
adults and children 12 years and over1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 yearsdo 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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

1-800-426-9391

HOW SUPPLIED

HOW SUPPLIED SECTION

Chlorpheniramine Maleate 4 mg

  • NDC 71335-2056-1: 30 Tablets in a BOTTLE
  • NDC 71335-2056-2: 60 Tablets in a BOTTLE
  • NDC 71335-2056-3: 100 Tablets in a BOTTLE
  • NDC 71335-2056-4: 120 Tablets in a BOTTLE
  • NDC 71335-2056-5: 40 Tablets in a BOTTLE
  • NDC 71335-2056-6: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorpheniramine Maleate 4mg Tablet

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN104
1363309chlorpheniramine maleate 4 MG Oral TabletSCD104

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2056-1Allergy30 in 1 BOTTLE, PLASTICTABLET30104
71335-2056-2Allergy60 in 1 BOTTLE, PLASTICTABLET60104
71335-2056-3Allergy100 in 1 BOTTLE, PLASTICTABLET100104
71335-2056-4Allergy120 in 1 BOTTLE, PLASTICTABLET120104
71335-2056-5Allergy40 in 1 BOTTLE, PLASTICTABLET40104
71335-2056-6Allergy24 in 1 BOTTLE, PLASTICTABLET24104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2056ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 6 package rows20250514_c948e612-a491-4ad0-adb9-cf31ef76e4d8.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
71335-205671335-2056-1, 71335-2056-2, 71335-2056-3, 71335-2056-4, 71335-2056-5, 71335-2056-6
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
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB

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
AllergyCHLORPHENIRAMINE MALEATEBryant Ranch Prepackc948e612-a491-4ad0-adb9-cf31ef76e4d82025-05-12WarningsExact identifier
ndc (package): 71335-2056-1
ndc (package): 71335-2056-6
ndc (package): 71335-2056-5
ndc (package): 71335-2056-3
ndc (package): 71335-2056-2
ndc (package): 71335-2056-4
ndc (product): 71335-2056
ndc11 (package): 71335205606
ndc11 (package): 71335205603
ndc11 (package): 71335205605
ndc11 (package): 71335205602
ndc11 (package): 71335205601
ndc11 (package): 71335205604
spl id: 34f743fa-bc37-3fa0-e063-6394a90a67d0
spl set id: c948e612-a491-4ad0-adb9-cf31ef76e4d8

Reported adverse events (FAERS/openFDA)#

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