SUDOGEST- pseudoephedrine hcl tablet, coated 
A-S Medication Solutions

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 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

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

Label Image
SUDOGEST 
pseudoephedrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1955(NDC:0904-6338)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL016
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-1955-028 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/17/2014
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1955) , REPACK(50090-1955)

Revised: 1/2020
Document Id: 62d1bcb9-2e0f-4d78-baff-23b99d8039a2
Set id: 13cb7a7c-127b-4972-ab1c-565bc2286a5c
Version: 7
Effective Time: 20200118
 
A-S Medication Solutions