Allergy Relief

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:00

Label at a glance#

ProductAllergy Relief 4 Hour
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

• 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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN4
1363309chlorpheniramine maleate 4 MG Oral TabletSCD4

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
57896-974-012021-02-15C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)
57896-974-102021-02-15C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)
57896-974-012021-01-29C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)
57896-974-102021-01-29C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-974-01Allergy Relief4 Hour100 in 1 BOTTLETABLET1004
57896-974-10Allergy Relief4 Hour1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-974ALLERGY RELIEF 4 HOUR (CHLORPHENIRAMINE MALEATE) TABLET [GERI-CARE PHARMACEUTICAL CORP]4Current NDC, Legacy NDC, 2 package rows20231027_92d90b41-0627-121e-e053-2995a90a2df1.zip

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
57896-97457896-974-01, 57896-974-10

Ingredients#

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

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEGeri-Care Pharmaceutical Corp92d90b41-0627-121e-e053-2995a90a2df12023-10-26WarningsExact identifier
ndc (package): 57896-974-01
ndc (package): 57896-974-10
ndc (product): 57896-974
ndc11 (package): 57896097401
ndc11 (package): 57896097410
spl id: 08a1af20-70f6-8c75-e063-6394a90a5ec1
spl set id: 92d90b41-0627-121e-e053-2995a90a2df1

Reported adverse events (FAERS/openFDA)#

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