FDA.reportPublic FDA data

SUDAFED Sinus Congestion

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:36:01

Label at a glance#

ProductSUDAFED Sinus Congestion
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 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

store between 20 - 25°C (68 - 77°F) do not use if blister unit is torn or broken see side panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - DO NOT USE SECTION

Do not use 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
  • 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 yearsdo not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • store between 20 - 25°C (68 - 77°F)
  • do not use if blister unit is torn or broken
  • see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREVIOUSLY SUDAFED ® CONGESTION
NDC 50580-363-02

SUDAFED ®

SINUS
CONGESTION

Pseudoephedrine HCl 30 mg,
Nasal Decongestant

actual size

MAXIMUM STRENGTH

  • SINUS PRESSURE
  • SINUS CONGESTION

24 TABLETS

NON-DROWSY

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN7
1049529SUDAFED 30 MG Oral TabletPSN7
1049529pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudafed]SBD7
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD7
1049529Sudafed 30 MG Oral TabletSY7

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
50580-363-01SUDAFED Sinus Congestion4 in 1 CARTONTABLET, FILM COATED47
50580-363-01SUDAFED Sinus Congestion12 in 1 BLISTER PACKTABLET, FILM COATED127
50580-363-02SUDAFED Sinus Congestion12 in 1 BLISTER PACKTABLET, FILM COATED127
50580-363-02SUDAFED Sinus Congestion2 in 1 CARTONTABLET, FILM COATED27
50580-363-03SUDAFED Sinus Congestion2 in 1 CARTONTABLET, FILM COATED27
50580-363-03SUDAFED Sinus Congestion3 in 1 PACKAGETABLET, FILM COATED37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-363SUDAFED SINUS CONGESTION (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 6 package rows20241109_c05d7e27-6821-468f-b27d-9c0b02a07b0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-363-02EA - Each50580-36301e83130-ad41-475c-b75e-e12f17e0c78b12024-04-05
50580-363-03EA - Each50580-3639dff6b70-befc-48c0-bd65-f01ec7b83b4d12023-05-05

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-36350580-363-01, 50580-363-02, 50580-363-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

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
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
ndc (package): 50580-363-03
ndc (package): 50580-363-02
ndc (package): 50580-363-01
ndc (product): 50580-363
ndc11 (package): 50580036301
ndc11 (package): 50580036302
ndc11 (package): 50580036303
spl id: 21707bfd-d78e-0f04-e063-6294a90a8945
spl set id: c05d7e27-6821-468f-b27d-9c0b02a07b0f

Reported adverse events (FAERS/openFDA)#

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