FDA.reportPublic FDA data

Chlorpheniramine Maleate

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
daily-update
Hydrated at
2026-08-12 01:01:03

Label at a glance#

ProductChlorpheniramine Maleate
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure9 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, 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

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from excessive moisture use by expiration date on package TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE

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:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • 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
  • 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
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

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 (800-222-1222).

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

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive moisture
  • use by expiration date on package
  • TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorpheniramine Maleate 4 mg
Antihistamine

55289560 Label
55289560 Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00355289560241(21)I19D650005(17)210930(10)I19D65GTIN-14: 00355289560241
GTIN-12: 355289560241
UPC-A: 355289560241
EAN-13: 0355289560241
GTIN storage (14 digits): 00355289560241		55289560.jpg
BarcodeEAN-130355289560241GTIN-13: 0355289560241
EAN-13: 0355289560241
GTIN-12: 355289560241
UPC-A: 355289560241
GTIN storage (14 digits): 00355289560241		55289560.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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-560-01EA - Each55289-560b7915648-3e45-477d-8f8b-46810defb09812021-04-08
55289-560-24EA - Each55289-560a1d1dfee-734f-4ae5-b94c-970d416355aa12021-04-08
55289-560-30EA - Each55289-560f26ad527-c69d-4385-9f27-5e656b5e05d712021-04-08
0536-1006-01EA - Each0536-1006270e3d12-6807-4d73-a4ac-8095b9e4ddd112015-01-05
0536-1006-10EA - Each0536-1006408f78fc-0a2b-4ee6-bf90-2376920c842712014-10-03
0536-1006-35EA - Each0536-100612500282-7eed-43ac-ae9d-c106fee7987812014-06-03

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
55289-56055289-560-24, 55289-560-30, 55289-560-01
0536-1006

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
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
182025-06-27full-release2026-06-01 01:06:30

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
Chlorpheniramine MaleateCHLORPHENIRAMINE MALEATEPD-Rx Pharmaceuticals, Inc.7a3452a2-930f-48b1-8c59-dbceb10b9c782026-08-10WarningsExact identifier
ndc (package): 55289-560-24
ndc (package): 55289-560-01
ndc (package): 55289-560-30
ndc (product): 55289-560
ndc11 (package): 55289056001
ndc11 (package): 55289056024
ndc11 (package): 55289056030
spl id: 58b37d44-1440-96f3-e063-6394a90a45db
spl set id: 7a3452a2-930f-48b1-8c59-dbceb10b9c78
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
ndc (product): 0536-1006

Reported adverse events (FAERS/openFDA)#

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