SUDOGEST NASAL DECONGESTANT- pseudoephedrine hcl tablet, film coated 
Major Pharmaceuticals

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

Principal Display Panel

COMPARE TO the active ingredient of SUDAFED® CONGESTION

SudoGest ™

NASAL DECONGESTANT

Pseudoephedrine Hydrochloride

Nasal & Sinus Congestion

Sinus Pressure

Actual Size

MAXIMUM STRENGTH

NON-DROWSY

24 TABLETS 30 mg EACH

sudogest-nasal-decongestant-image
SUDOGEST NASAL DECONGESTANT 
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (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:0904-6337-2424 in 1 CARTON09/10/1991
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/10/1991
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2018
Document Id: 8bf24642-97e0-4ad1-8156-2142a1267eda
Set id: 5229f4b2-a194-46f8-a0bc-4510fbe52075
Version: 4
Effective Time: 20181012
 
Major Pharmaceuticals