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SudoGest by Rebel Distributors Corp

Medically reviewed on March 6, 2018

Dosage form: tablet
Ingredients: Pseudoephedrine Hydrochloride 30mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-806

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

DRUG FACTS

 

Active Ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

PURPOSE

Nasal decongestant

USES
  • 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

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 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
  • you get nervous, dizzy or sleepless
  • 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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions
  • take every 4 to 6 hours
  • do not exceed 4 doses in 24 hours

adults and children 12 years & over 2 tablets 
children 6 to under 12 years 1 tablet 
children under 6 years ask a doctor 

OTHER INFORMATION
  • store at controlled room temperature 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

SUDOGEST 
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-806(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 Code44112
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-806-1212 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/1994
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

See Also

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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