SudoGest Nasal Decongestant

Manufacturer
A-S Medication Solutions
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:35:17

Label at a glance#

ProductSUDOGEST NASAL DECONGESTANT
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

• 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

  • 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

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

1-800-616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4345

NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON

Pseudoephedrine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN10
1049162SudoGest 30 MG Oral TabletPSN10
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD10
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD10
1049162Sudogest 30 MG Oral TabletSY10

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4345-0SUDOGEST NASAL DECONGESTANT48 in 1 BOTTLETABLET, FILM COATED4810
50090-4345-1SUDOGEST NASAL DECONGESTANT1 in 1 BLISTER PACKTABLET, FILM COATED110
50090-4345-1SUDOGEST NASAL DECONGESTANT24 in 1 CARTONTABLET, FILM COATED2410
50090-4345-2SUDOGEST NASAL DECONGESTANT12 in 1 BOTTLETABLET, FILM COATED1210
50090-4345-3SUDOGEST NASAL DECONGESTANT30 in 1 BOTTLETABLET, FILM COATED3010
50090-4345-4SUDOGEST NASAL DECONGESTANT4 in 1 BOTTLETABLET, FILM COATED410
50090-4345-5SUDOGEST NASAL DECONGESTANT15 in 1 BOTTLETABLET, FILM COATED1510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4345SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 7 package rows20241109_09feb5f0-c22d-4a1b-97a0-d5767e5f7730.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4345-1EA - Each50090-4345a510bcc2-0b21-485b-b9e5-434600a4917112022-09-12
0904-6337-24EA - Each0904-633764127ff8-f200-4b9f-8e6e-4def259e840312019-05-02

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
50090-434550090-4345-1, 50090-4345-0, 50090-4345-2, 50090-4345-3, 50090-4345-4, 50090-4345-5
0904-6337

Ingredients#

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

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SudoGest Nasal DecongestantPSEUDOEPHEDRINE HCLMajor Pharmaceuticals5229f4b2-a194-46f8-a0bc-4510fbe520752025-12-15WarningsExact identifier
ndc (product): 0904-6337
SUDOGEST NASAL DECONGESTANTPSEUDOEPHEDRINE HCLA-S Medication Solutions09feb5f0-c22d-4a1b-97a0-d5767e5f77302024-11-07WarningsExact identifier
ndc (package): 50090-4345-2
ndc (package): 50090-4345-3
ndc (package): 50090-4345-5
ndc (package): 50090-4345-4
ndc (package): 50090-4345-1
ndc (package): 50090-4345-0
ndc (product): 50090-4345
ndc11 (package): 50090434501
ndc11 (package): 50090434503
ndc11 (package): 50090434502
ndc11 (package): 50090434500
ndc11 (package): 50090434504
ndc11 (package): 50090434505
spl id: 72064c3e-8348-4230-b2e3-47a03e3467df
spl set id: 09feb5f0-c22d-4a1b-97a0-d5767e5f7730

Reported adverse events (FAERS/openFDA)#

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