SudoGest 30 mg Tablets

Manufacturer
A-S Medication Solutions
Effective date
2020-01-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:03:15

Label at a glance#

ProductSudoGest
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

INDICATIONS AND USAGE: Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis Temporarily relieves sinus congestion and pressure

Dosage and administration

DOSAGE AND ADMINISTRATION: Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours Adults and children 12 years and over – 2 tablets Children 6 to under 12 years – 1 tablet Children under 6 years – do not use

Storage and handling

Store at 25ºC (77ºF). Excursions permitted between 15º-30ºC (59º-86ºF). Protect from light.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

In each tablet Pseudoephedrine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

  Nasal Decongestant

Keep out of reach of children

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

Indications and Usage

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE:

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis

Temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

WARNINGS: 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.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION:

Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours

Adults and children 12 years and over – 2 tablets

Children 6 to under 12 years – 1 tablet

Children under 6 years – do not use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:  acacia, calcium sulfate, carnauba Wax. colloidal silicon dioxide, corn starch, D-C red no. 27, D-C yellow no.10, FD-C red no.40, FD-C yellow  no 6, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre) Kaolin, microcrystalline cellulose, polyethylene glycol (PEG) 400, , pregelatinized starch, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

 1-800-616-2471

Storage

STORAGE AND HANDLING SECTION

Store at 25ºC (77ºF). Excursions permitted between 15º-30ºC (59º-86ºF).

Protect from light.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1955

NDC: 50090-1955-0 28 TABLET, COATED in a BOTTLE

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 TabletPSN7
1049162SudoGest 30 MG Oral TabletPSN7
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD7
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD7
1049162Sudogest 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1955-02023-01-30C16284748780-1f386c649-d06a-0266-e053-dadaa90a7c1aSudoGest 30 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1955-0SudoGest28 in 1 BOTTLETABLET, COATED287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1955SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20200121_13cb7a7c-127b-4972-ab1c-565bc2286a5c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1955-0EA - Each50090-1955ef7a300a-1a15-41d6-82f4-b6489880350f12018-11-06

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-195550090-1955-0
0904-6338

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62d1bcb9-2e0f-4d78-baff-23b99d8039a213cb7a7c-127b-4972-ab1c-565bc2286a5c2020-01-18WarningsExact identifier
spl id: 62d1bcb9-2e0f-4d78-baff-23b99d8039a2
spl set id: 13cb7a7c-127b-4972-ab1c-565bc2286a5c

Reported adverse events (FAERS/openFDA)#

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