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SudoGest by H.J. Harkins Company, Inc.

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: H.J. Harkins Company, Inc.
NDC Code: 52959-260

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

MAJOR®

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 0904-5125-59

SudoGest™

NASAL DECONGESTANT  60 mg

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

100 TABLETS

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

Repacked by H.J. Harkins Company, Inc.

Nipomo, CA 93444

Rev. 10/11      Re-order No. 700324

Product Packaging

SUDOGEST 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-260(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:52959-260-00100 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC
2NDC:52959-260-2020 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
3NDC:52959-260-2424 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
4NDC:52959-260-2525 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
5NDC:52959-260-3030 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
6NDC:52959-260-4040 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
7NDC:52959-260-6060 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/1994
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIOperations
H.J. Harkins Company, Inc.147681894repack, relabel

Revised: 01/2012
 
H.J. Harkins Company, Inc.

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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