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SudoGest by Major Pharmaceuticals

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5053

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.

Major 44-112

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal Congestant

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 2 weeks after stoppin the MAOI drug.  If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • diabetes
  • high blood pressure
  • heart disease
  • 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 pregnant 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 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
24 hours 
children ages 6 to 12 yearstake 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours 
children under 6 yearsdo not use this product in children
under 6 years of age 

Other information
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments? 1-800-426-9391

Principal Display Panel

SEALED IN BLISTER UNIT FOR YOUR PROTECTION

MAJOR®

NDC 0904-5053-24

Non-Drowsy
SudoGest™
NASAL DECONGESTANT
Pseudoephedrine Hydrochloride 30 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

*Compare to the active ingredient in Sudafed® Congestion

24 TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
50844         REV0712J11208

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA          M-17
Rev. 08/12
Re-order No. 235623

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Major 44-112

SUDOGEST 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5053
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;112
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5053-241 BLISTER PACK (1 CARTON) in 1 BLISTER PACK
124 TABLET (24 TABLET) in 1 BLISTER PACK
2NDC:0904-5053-591 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
2100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/1981
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-5053)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-5053)

Revised: 08/2013
 
Major Pharmaceuticals

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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