SUDOGEST- pseudoephedrine hydrochloride tablet

SudoGest by

Drug Labeling and Warnings

SudoGest by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DOSAGE & ADMINISTRATION

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

INGREDIENTS AND APPEARANCE

SUDOGEST 
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-806(NDC:0904-5053)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	30 mg

Inactive Ingredients
Ingredient Name	Strength
Croscarmellose Sodium (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Polydextrose (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
Titanium Dioxide (UNII: 15FIX9V2JP)
Triacetin (UNII: XHX3C3X673)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44112
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-806-12	12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/1994

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK