SUDOGEST NASAL DECONGESTANT- pseudoephedrine hcl tablet, film 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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Major Pharmaceuticals SudoGest Nasal Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

•
temporarily relieves sinus congestion and pressure
•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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.

Ask a doctor before use if you have

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

•
nervousness, dizziness, or sleeplessness occur
•
symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

adults and children 12 years and over
•
take 2 tablets every 4 to 6 hours
•
do not take more than 8 tablets in 24 hours

children ages 6 to 11 years
•
take 1 tablet every 4 to 6 hours
•
do not take more than 4 tablets in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other information

•
each tablet contains: calcium 20 mg
•
store at 20°-25°C (68°-77°F)
•
do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-800-616-2471

HOW SUPPLIED

Product: 50090-4345

NDC: 50090-4345-1 1 TABLET, FILM COATED in a BLISTER PACK / 24 in a CARTON

NDC: 50090-4345-0 48 TABLET, FILM COATED in a BOTTLE

NDC: 50090-4345-2 12 TABLET, FILM COATED in a BOTTLE

NDC: 50090-4345-3 30 TABLET, FILM COATED in a BOTTLE

NDC: 50090-4345-4 4 TABLET, FILM COATED in a BOTTLE

NDC: 50090-4345-5 15 TABLET, FILM COATED in a BOTTLE

Pseudoephedrine HCl

Label Image
SUDOGEST NASAL DECONGESTANT 
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4345(NDC:0904-6337)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScoreno score
ShapeROUND (convex) Size7mm
FlavorImprint Code L432
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4345-124 in 1 CARTON06/10/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50090-4345-212 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
3NDC:50090-4345-515 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
4NDC:50090-4345-330 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
5NDC:50090-4345-44 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
6NDC:50090-4345-048 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/10/1991
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4345)

Revised: 2/2023
Document Id: 7e1ef9b9-048c-4240-bcca-d3bd60cf5ced
Set id: 09feb5f0-c22d-4a1b-97a0-d5767e5f7730
Version: 7
Effective Time: 20230206
 
A-S Medication Solutions