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SudoGest by Major Pharmaceuticals

Dosage form: tablet, coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6338

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 30 mg Tablets

Active Ingredient

In each tablet Pseudoephedrine HCl 30 mg

Purpose

  Nasal Decongestant

Keep out of reach of children

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away

Indications and Usage

INDICATIONS AND USAGE:

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis

Temporarily relieves sinus congestion and pressure


Warnings

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.

Dosage and Administration

DOSAGE AND ADMINISTRATION:

Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours

Adults and children 12 years and over – 2 tablets

Children 6 to under 12 years – 1 tablet

Children under 6 years – do not use

Inactive Ingredients

INACTIVE INGREDIENTS:  acacia, calcium sulfate, carnauba Wax. colloidal silicon dioxide, corn starch, D-C red no. 27, D-C yellow no.10, FD-C red no.40, FD-C yellow  no 6, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre) Kaolin, microcrystalline cellulose, polyethylene glycol (PEG) 400, , pregelatinized starch, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Principal Display Panel

 

Questions or Comments?

 1-800-616-2471

Storage

Store at 25ºC (77ºF). Excursions permitted between 15º-30ºC (59º-86ºF).

Protect from light.

SUDOGEST 
pseudoephedrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6338
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C RED NO. 27 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
KAOLIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeTCL016
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6338-60100 TABLET, COATED (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/17/2014
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

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Medically reviewed on Feb 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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