SUDOGEST 12 HOUR- pseudoephedrine hcl tablet, film coated, extended release 
Major Pharmaceuticals

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Major Pharmaceuticals SudoGest™ 12 Hour Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•
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 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 1 tablet every 12 hours
•
do not take more than 2 tablets in 24 hours

children under 12 years

do not use this product in children under 12 years of age

Other information

•
each tablet contains: calcium 45 mg
•
store at 20-25°C (68-77°F) in a dry place
•
protect from light
•
do not use if blister unit is broken or torn
•
see carton end panel for lot number and expiration date
•
this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

MAJOR®

compare to the active ingredient in Sudafed® Sinus Congestion 12 Hour Caplets

maximum strength

SudoGest™ 12 hour

pseudoephedrine hydrochloride extended release tablets, 120 mg

nasal decongestant

• sinus pressure

• congestion

non-drowsy

gluten free sinus

10 coated caplets* (120 mg each)

*capsule-shaped tablets

actual size

major-sudogest-12-hour-carton-image-1.jpg
major-sudogest-12-hour-carton-image-2.jpg
SUDOGEST 12 HOUR 
pseudoephedrine hcl tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6754
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code L054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6754-1510 in 1 CARTON02/12/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515302/12/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2025
Document Id: a689a700-468b-45ac-8849-371a604587f4
Set id: e829aab0-3ef0-4149-8197-96c5ce0b31d2
Version: 4
Effective Time: 20251030
 
Major Pharmaceuticals