Allergy

Manufacturer
Marc Glassman, Inc.
Effective date
2016-12-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:56:50

Label at a glance#

ProductAllergy
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure8 sections

Indications and uses

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

Dosage and administration

■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours ■ Adults and children 12 years and over: 1 tablet ■ Children 6 to under 12 years: 1/2 tablet ■ Children under 6 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

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:

■ sneezing

■ runny nose

■ itchy watery eyes

■ itching of the nose or throat

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma or

■ trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ marked drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when drivinga motor vehicle or operating machinery 

■ excitability may occur especially in children

Pregnancy/Breastfeeding

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 accidental overdose, contact a doctor or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ take every 4 to 6 hours

■ do not take more than 6 doses in 24 hours

■ Adults and children 12 years and over: 1 tablet

■ Children 6 to under 12 years: 1/2 tablet

■ Children under 6 years: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

 ■ Store at room temperature in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Allergy ReliefAllergy Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN6
1363309chlorpheniramine maleate 4 MG Oral TabletSCD6

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
68998-277-93Allergy1 in 1 CARTONTABLET, COATED16
68998-277-93Allergy24 in 1 BLISTER PACKTABLET, COATED246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-277ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET, COATED [MARC GLASSMAN, INC.]6Current NDC, Legacy NDC, 2 package rows20231018_2051247f-ce64-4cf5-b449-9ca14c43ab86.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68998-27768998-277-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
ndc (package): 68998-277-93
ndc (product): 68998-277
ndc11 (package): 68998027793
spl id: 260b7a08-4f47-40ca-aa36-7647d20d7edd
spl set id: 2051247f-ce64-4cf5-b449-9ca14c43ab86

Reported adverse events (FAERS/openFDA)#

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