FDA.reportPublic FDA data

Anti-Allergy Tablets Antihistamine

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:48

Label at a glance#

ProductAnti Allergy
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies : runny nose itchy nose or throat sneezing itchy, watery eyes

Dosage and administration

Adults & children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours children 6 years to under 12 years take ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours children under 6 years do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Chlorpheniramine Maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies :

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating a machine
  • excitability may occur, especially in children

    If pregnant or breast-feeding, 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[/S]

DOSAGE & ADMINISTRATION SECTION

Adults & children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 yearstake ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
children under 6 yearsdo not use

Other Information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 40 mg
  • store between 15°-30°C (59°-86°F)
  • protect from moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

Questions or Comments

OTC - QUESTIONS SECTION

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorpheniramine Maleate 4 mg

Antihistamine

NDC: 54738-103-01 - 100 CPM tablets

IMG_4672IMG_4672

NDC: 54738-103-03 - 1000 CPM tablets

NDC: 54738-103-14 - 24 CPM tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN2
1363309chlorpheniramine maleate 4 MG Oral TabletSCD2

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
BarcodeEAN-130054738103014GTIN-13: 0054738103014
EAN-13: 0054738103014
GTIN-12: 054738103014
UPC-A: 054738103014
GTIN storage (14 digits): 00054738103014		IMG_4672.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
54738-103-01Anti Allergy100 in 1 BOTTLETABLET1002
54738-103-03Anti Allergy1000 in 1 BOTTLETABLET10002
54738-103-14Anti Allergy24 in 1 BOTTLETABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-103ANTI ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20171030_316db99f-5a13-48e0-9a6b-ab7a76fe4d28.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-103-01EA - Each54738-1033ba3deb0-2c3a-4c8a-aa9f-4fbfca573a3e12017-11-06
54738-103-03EA - Each54738-10308895da8-8ff1-40c0-8d86-2123a788d39412017-11-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54738-10354738-103-01, 54738-103-03, 54738-103-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti AllergyCHLORPHENIRAMINE MALEATERichmond Pharmaceuticals, Inc.316db99f-5a13-48e0-9a6b-ab7a76fe4d282017-10-30WarningsExact identifier
ndc (package): 54738-103-03
ndc (package): 54738-103-14
ndc (package): 54738-103-01
ndc (product): 54738-103
ndc11 (package): 54738010303
ndc11 (package): 54738010301
ndc11 (package): 54738010314
spl id: 5cc3ebfe-ce74-423d-e053-2a91aa0a4616
spl set id: 316db99f-5a13-48e0-9a6b-ab7a76fe4d28

Reported adverse events (FAERS/openFDA)#

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