FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2026-03-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:49:30

Label at a glance#

ProductAllergy Relief
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

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)  protect from excessive moisture see end flap for expiration date and lot number

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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
  • 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

  • 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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
  • protect from excessive moisture
  • see end flap for expiration date and lot number

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

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCare
Health®

NDC 36800-694-08

Allergy Relief
 CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE

Relieves:
• Sneezing
• Itchy, Watery Eyes
• Runny Nose
• Itchy Throat

4
HOUR

24 TABLETS

actual
size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA1220 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

50844          ORG041919408

Topcare 44-194
Topcare 44-194

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN7
1363309chlorpheniramine maleate 4 MG Oral TabletSCD7

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-130036800215610GTIN-13: 0036800215610
EAN-13: 0036800215610
GTIN-12: 036800215610
UPC-A: 036800215610
GTIN storage (14 digits): 00036800215610		topcare-44-194-1.jpg
QR code linkQR Codetopbrnds.com/48zxx3topcare-44-194-1.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
36800-694-08Allergy Relief2 in 1 CARTONTABLET27
36800-694-08Allergy Relief12 in 1 BLISTER PACKTABLET127

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
36800-69436800-694-08

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

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 ReliefCHLORPHENIRAMINE MALEATETopco Associates, LLC35305aa9-4fc1-4cda-b6f0-89df64f9eeff2026-03-10WarningsExact identifier
ndc (package): 36800-694-08
ndc (product): 36800-694
ndc11 (package): 36800069408
spl id: 784f6f3d-c1fe-47a4-a388-6c5794fda5db
spl set id: 35305aa9-4fc1-4cda-b6f0-89df64f9eeff

Reported adverse events (FAERS/openFDA)#

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