SUDOGEST- pseudoephedrine hydrochloride tablet, film coated

SudoGest by

Drug Labeling and Warnings

SudoGest by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 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

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

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if

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

If pregrant 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: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• store at 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

Questions or comments?

(800)-616-2471

Principal display panel

FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.

NDC 0904-5125-46

MAJOR®

SudoGest™
NASAL DECONGESTANT  60 mg
Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever
Without Drowsiness

30 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA   Rev. 02/13    M-17

50844  REV0712G11301

Major 44-113

INGREDIENTS AND APPEARANCE

SUDOGEST 
pseudoephedrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;113
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5125-59	1 in 1 CARTON	12/07/1984	11/26/2021
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0904-5125-46	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/07/1984

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/07/1984

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0904-5125)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0904-5125)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0904-5125)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0904-5125)