SUDOGEST- pseudoephedrine hydrochloride tablet, film coated 
REMEDYREPACK INC.

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



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

DRUG: SudoGest

GENERIC: Pseudoephedrine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 52125-625-08

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: 44;113

PACKAGING: 10 in 1 VIAL

ACTIVE INGREDIENT(S):

  • PSEUDOEPHEDRINE HYDROCHLORIDE 60mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE
  • STEARIC ACID
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS

Remedy_Label

SUDOGEST 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52125-625(NDC:0904-5125)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;113
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52125-625-0810 in 1 VIAL; Type 0: Not a Combination Product10/02/201411/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/02/201411/16/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2017
Document Id: 45f0f0c9-1a48-186a-e054-00144ff8d46c
Set id: 4828c681-714c-44fa-8609-f0fd4eec4f42
Version: 5
Effective Time: 20170112
 
REMEDYREPACK INC.