SudoGest

Manufacturer
Rebel Distributors Corp
Effective date
2012-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:28

Label at a glance#

ProductSudoGest
Active ingredientPseudoephedrine Hydrochloride
Label structure10 sections

Indications and uses

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

take every 4 to 6 hours do not exceed 4 doses in 24 hours adults and children 12 years & over  2 tablets  children 6 to under 12 years  1 tablet  children under 6 years  ask a doctor 

Storage and handling

store at controlled room temperature 15˚-30˚C (59˚-86˚F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

DRUG FACTS

SPL UNCLASSIFIED SECTION

 

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 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

Do not use

SPL UNCLASSIFIED 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 contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

  • diabetes
  • thyroid disease
  • heart disease
  • high blood pressure
  • trouble urinating due to enlargement of the prostate gland

 

When using this product

SPL UNCLASSIFIED SECTION

  • do not exceed recommended dose

 

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with fever

If pregrant or breast-feeding,

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep out of the 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

SPL UNCLASSIFIED SECTION

  • take every 4 to 6 hours
  • do not exceed 4 doses in 24 hours

adults and children 12 years & over 2 tablets 
children 6 to under 12 years 1 tablet 
children under 6 years ask a doctor 

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C red #40, FD&C yellow #6, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sudogest 30mg (Nasal Decongestant)
Sudogest 30mg (Nasal Decongestant)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN1
1049162SudoGest 30 MG Oral TabletPSN1
1049162pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest]SBD1
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD1
1049162Sudogest 30 MG Oral TabletSY1

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-806-122019-09-24C16284748780-1934fe258-48c9-48b1-e053-8cdaa90a720aSudoGest Nasal Decongestant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-806-12SudoGest12 in 1 BLISTER PACKTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-806SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120420_656726ed-50cd-4f7e-8e51-e242afd1d9c9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-806-12EA - Each21695-8063f30db98-db4e-4242-9760-37e112e86dcf12012-07-24
0904-5053-24EA - Each0904-50535f294304-939e-4c0b-af84-6c0bb2f9bb1112012-07-24
0904-5053-59EA - Each0904-5053e6ec7cb2-becd-49b9-bed7-a75f6e1d888712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8N1
PseudoephedrineACTIVE MOIETY7CUC9DDI9F1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH481
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
PolydextroseINACTIVE INGREDIENTVH2XOU12IE1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
TriacetinINACTIVE INGREDIENTXHX3C3X6731

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-80621695-806-12
0904-5053

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
PolydextrosePOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route+dosage form
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
TriacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form

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
SudoGestPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsd46577aa-7fd7-2130-6ed6-4b3f7562491f2025-10-21WarningsExact identifier
ndc (product): 0904-5053
656726ed-50cd-4f7e-8e51-e242afd1d9c9656726ed-50cd-4f7e-8e51-e242afd1d9c92012-03-06WarningsExact identifier
spl id: 656726ed-50cd-4f7e-8e51-e242afd1d9c9
spl set id: 656726ed-50cd-4f7e-8e51-e242afd1d9c9

Reported adverse events (FAERS/openFDA)#

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