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Pseudoephedrine Hydrochloride by Physicians Total Care, Inc.

Medically reviewed on January 24, 2018

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-1973

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

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

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


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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code44;113
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-1973-120 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE
2NDC:54868-1973-3100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
3NDC:54868-1973-430 TABLET, FILM COATED (TABLET) 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/FEIOperations
Physicians Total Care, Inc.194123980relabel, repack

 
Physicians Total Care, Inc.

← See all Pseudoephedrine Hydrochloride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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