PSEUDOEPHEDRINE HYDROCHLORIDE - pseudoephedrine hydrochloride tablet, film coated 
Physicians Total Care, 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

Pseudoephedrine HCl 60 mg

Purpose

Nasal decongestant

Uses

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

Other information

Inactive ingredients

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

Principal display panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available


FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 54868-1973-1

image of package label

Pseudoephedrine Hydrochloride 60 mg

NASAL DECONGESTANT  60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


50844  Rev. 0807L11302

Distributed by Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA   M-17

Rev. 10/10      Re-order No. 700324



Relabeing and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146
PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1973(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)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL (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:54868-1973-120 in 1 BOTTLE
2NDC:54868-1973-3100 in 1 BOTTLE
3NDC:54868-1973-430 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/25/2002
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 1/2012
Document Id: 08081de2-2096-499e-b5b3-067fbbbef571
Set id: f709661d-ae6d-408a-9701-187f7f6f3fc6
Version: 1
Effective Time: 20120124
 
Physicians Total Care, Inc.