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SudoGest by Unit Dose Services

Medically reviewed on Feb 27, 2017

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Unit Dose Services
NDC Code: 50436-0333

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SudoGest
Nasal Decongestant

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 mg

Purpose

Nasal decongestant

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

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.

Ask a doctor before use if you have
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever

If pregrant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information
  • store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

Questions or comments?

(800)-616-2471

HOW SUPPLIED

Product: 50436-0333

NDC: 50436-0333-2 24 TABLET, FILM COATED in a BOTTLE

SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED
SUDOGEST 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-0333(NDC:0904-5125)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
STEARIC ACID 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code44;113
Contains    
Packaging
#Item CodePackage Description
1NDC:50436-0333-2 24 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/07/1984
Labeler - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-0333), RELABEL(50436-0333)

 
Unit Dose Services

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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