SUDOGEST - pseudoephedrine hydrochloride tablet
A-S Medication Solutions LLC

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.

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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

NDC 54569-0650-1

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048

SUDOGEST
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54569-0650(NDC:0904-5053)
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54569-0650-1	24 in 1 BLISTER PACK

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

Labeler - A-S Medication Solutions LLC (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions LLC		830016429	relabel(54569-0650)

Revised: 6/2013

Document Id: 434ee84d-8987-47a9-9e6c-3634ff83e5e2

Set id: cbd9f197-b0aa-4f23-a608-cd85e9a35dc0

Version: 1

Effective Time: 20130617

A-S Medication Solutions LLC

SudoGestNasal Decongestant