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Name:Sudogest
Manufacturer:Bryant Ranch Prepack
Category:Prescription Marketed Drugs


SudoGest

SUDOGEST - pseudoephedrine hydrochloride tablet, film coated 
Bryant Ranch Prepack

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.

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SudoGest

Active ingredient

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
  • thyroid disease
  • heart disease
  • high blood pressure
  • trouble urinating due to enlargement of the 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 controlled room temperature 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

Pseudoephedrine Hcl 60mg Tablet

Image File

SUDOGEST 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1491(NDC:0904-5125)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
LACTOSE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL  
SILICON DIOXIDE  
STEARIC ACID  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 44;113
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-1491-4 60 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
2 NDC:63629-1491-2 30 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
3 NDC:63629-1491-1 20 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
4 NDC:63629-1491-3 15 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
5 NDC:63629-1491-5 14 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/01/1994

Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK, RELABEL

Revised: 10/1994 Bryant Ranch Prepack



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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