FDA.reportPublic FDA data

Topcare Nasal Decongestant

Manufacturer
Topco Associates LLC
Effective date
2024-09-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:19:55

Label at a glance#

ProductTopcare Nasal Decongestant Maximum Strength Non Drowsy
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and administration

adults and children 12 years and over • take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 years • take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age

Storage and handling

• each tablet contains: calcium 20 mg • store at 20 ° -25 ° C (68 ° -77 ° F) • do not use if blister unit is broken or torn

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  1. heart disease
  2. high blood pressure
  3. thyroid disease
  4. diabetes
  5. trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over

  1. take 2 tablets every 4 to 6 hours
  2. do not take more than 8 tablets in 24 hours

children ages 6 to 11 years

  1. take 1 tablet every 4 to 6 hours
  2. do not take more than 4 tablets in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

COMPARE TO SUDAFED® CONGESTION ACTIVE INGREDIENT

NON-DROWSY

Nasal Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, 30 mg

MAXIMUM STRENGTH

• Sinus Pressure + Congestion

• Pseudoephedrine HCl

24 TABLETS

actual size

432-88-nasal-decongestant
432-88-nasal-decongestant

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN8
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-432-62Topcare Nasal DecongestantMaximum Strength Non Drowsy24 in 1 CARTONTABLET, FILM COATED248
36800-432-62Topcare Nasal DecongestantMaximum Strength Non Drowsy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-432-67Topcare Nasal DecongestantMaximum Strength Non Drowsy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-432-67Topcare Nasal DecongestantMaximum Strength Non Drowsy48 in 1 CARTONTABLET, FILM COATED488
36800-432-80Topcare Nasal DecongestantMaximum Strength Non Drowsy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-432-80Topcare Nasal DecongestantMaximum Strength Non Drowsy96 in 1 CARTONTABLET, FILM COATED968

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-432TOPCARE NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20240922_1a9e0336-c0c2-43f8-aeea-668d4a209714.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-432-62EA - Each36800-432e688effe-a22f-4e07-b766-82c2909e1fac12012-07-24
36800-432-67EA - Each36800-432430e347c-ad87-4607-a232-776f86755ca112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-43236800-432-62, 36800-432-67, 36800-432-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CARNAUBA WAXR12CBM0EIZIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT

Source Document#

Source XML · Source PDF

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
Topcare Nasal Decongestant Maximum Strength Non DrowsyPSEUDOEPHEDRINE HCLTopco Associates LLC1a9e0336-c0c2-43f8-aeea-668d4a2097142024-09-20WarningsExact identifier
ndc (package): 36800-432-62
ndc (package): 36800-432-80
ndc (package): 36800-432-67
ndc (product): 36800-432
ndc11 (package): 36800043262
ndc11 (package): 36800043267
ndc11 (package): 36800043280
spl id: 37431858-f49a-49f8-a633-da70c27490bd
spl set id: 1a9e0336-c0c2-43f8-aeea-668d4a209714

Reported adverse events (FAERS/openFDA)#

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