Sudogest (Pseudoephedrine Hcl) Tablet, Coated [A-S Medication Solutions] -

SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, COATED [A-S MEDICATION SOLUTIONS]
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NDC	50090-1955-0
Set ID	13cb7a7c-127b-4972-ab1c-565bc2286a5c
Category	HUMAN OTC DRUG LABEL
Packager	A-S Medication Solutions
Generic Name
Product Class	alpha-Adrenergic Agonist
Product Number
Application Number	PART341

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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
Questions or Comments?

1-800-616-2471
Storage

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

Protect from light.
HOW SUPPLIED

Product: 50090-1955

NDC: 50090-1955-0 28 TABLET, COATED in a BOTTLE
PSEUDOEPHEDRINE HCL

INGREDIENTS AND APPEARANCE

SUDOGEST
pseudoephedrine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-1955(NDC:0904-6338)
Route of Administration	ORAL

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
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
KAOLIN (UNII: 24H4NWX5CO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL016
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50090-1955-0	28 in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/17/2014

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-1955) , REPACK(50090-1955)

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