SUDOGEST- pseudoephedrine hydrochloride tablet, film coated, extended release 
Major Pharmaceuticals

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Pseudoephedrine HCl USP, 120 mg

PURPOSE

Nasal decongestant

USES

temporarily relieves nasal congestion due to:

•
common cold
•
hay fever
•
upper respiratory allergies
•
temporarily restores freer breathing through the nose
•
promotes nasal and/or sinus drainage
•
temporarily relieves sinus congestion and pressure

WARNINGS

Do not use

if you are 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
•
diabetes
•
thyroid disease
•
trouble urinating due to an enlarged prostate gland

When using this product

•
do not use more than directed

Stop use and ask a doctor if

•
symptoms do not get better within 7 days or occur with a fever
•
you get nervous, dizzy, or sleepless

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.

DIRECTIONS

•
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
•
children under 12 years: ask a doctor

OTHER INFORMATION

•
store at 59° to 77° F in a dry place
•
protect from light
•
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

QUESTIONS?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

LIVONIA, MI 48150, USA

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-5803-15

SudoGest 12 HOUR

Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg

LONG-ACTING NASAL DECONGESTANT

RELIEVES:

•
NASAL & SINUS CONGESTION DUE TO COLDS & ALLERGIES
•
SINUS PRESSURE

MAXIMUM STRENGTH

NON-DROWSY

10 COATED CAPLETS*

(120 mg EACH)

*Capsule-Shaped Tablets

COMPARE TO the active ingredient of SUDAFED®12 HOUR**

**This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED®12 Hour.

This is the 10 count blister carton label for Major SudoGest 12 hour caplets.
SUDOGEST 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5803
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
CASTOR OIL (UNII: D5340Y2I9G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5803-1510 in 1 BLISTER PACK; Type 0: Not a Combination Product04/28/200608/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744204/28/200608/31/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020
Document Id: 728a3e68-532a-410b-b67c-6d53e54003f3
Set id: 4ea51d10-4fb8-4fc3-b6b0-1ffef3085b97
Version: 2
Effective Time: 20200103
 
Major Pharmaceuticals