FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Bryant Ranch Prepack
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:45:59

Label at a glance#

ProductAllergy Relief 4 Hour
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

• do not exceed recommended dose • adults and children 12 years and over: take 1 tablet every 4 to 6 hours, as needed, not more than 6 tablets in 24 hours or as directed by a doctor • children under 12: consult a doctor

Storage and handling

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken. • store at 20-25°C (68-77°F); excursions permitted between 15°-30°C (59°-86°F) • protect from 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, 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

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

• do not exceed recommended dose
• adults and children 12 years and over: take 1 tablet every 4 to 6 hours,
as needed, not more than 6 tablets in 24 hours or as directed by a doctor
• children under 12: consult a doctor

Other information

STORAGE AND HANDLING SECTION

• Tamper Evident: Do not use if imprinted seal
under cap is missing or broken. • store at 20-25°C (68-77°F);
excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture

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

1-800-540-3765

HOW SUPPLIED

How Supplied Section

Chlorpheniramine Maleate 4mg Tablets

  • NDC 71335-3093-1: 30 Tablets in a BOTTLE
  • NDC 71335-3093-2: 60 Tablets in a BOTTLE
  • NDC 71335-3093-3: 100 Tablets in a BOTTLE
  • NDC 71335-3093-4: 120 Tablets in a BOTTLE
  • NDC 71335-3093-5: 40 Tablets in a BOTTLE
  • NDC 71335-3093-6: 24 Tablets in a BOTTLE

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorpheniramine Maleate 4mg Tablets

Label
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
BarcodeData Matrix(01)00371335309312(21)0123456789(17)280217(10)208820GTIN-14: 00371335309312
GTIN-12: 371335309312
UPC-A: 371335309312
EAN-13: 0371335309312
GTIN storage (14 digits): 00371335309312		lbl713353093.jpg
Data codeCode 1287133530931lbl713353093.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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3093-1Allergy Relief4 Hour30 in 1 BOTTLETABLET301
71335-3093-2Allergy Relief4 Hour60 in 1 BOTTLETABLET601
71335-3093-3Allergy Relief4 Hour100 in 1 BOTTLETABLET1001
71335-3093-4Allergy Relief4 Hour120 in 1 BOTTLETABLET1201
71335-3093-5Allergy Relief4 Hour40 in 1 BOTTLETABLET401
71335-3093-6Allergy Relief4 Hour24 in 1 BOTTLETABLET241

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
71335-309371335-3093-1, 71335-3093-2, 71335-3093-3, 71335-3093-4, 71335-3093-5, 71335-3093-6
57896-974

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. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
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
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
ndc (package): 71335-3093-3
ndc (package): 71335-3093-5
ndc (package): 71335-3093-6
ndc (package): 71335-3093-1
ndc (package): 71335-3093-4
ndc (package): 71335-3093-2
ndc (product): 71335-3093
ndc11 (package): 71335309301
ndc11 (package): 71335309305
ndc11 (package): 71335309303
ndc11 (package): 71335309302
ndc11 (package): 71335309306
ndc11 (package): 71335309304
spl id: a42deed3-3328-4690-8709-6ba9da4d1bd9
spl set id: 09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEGeri-Care Pharmaceutical Corp92d90b41-0627-121e-e053-2995a90a2df12023-10-26WarningsExact identifier
ndc (product): 57896-974

Reported adverse events (FAERS/openFDA)#

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