SUDOGEST- pseudoephedrine hydrochloride 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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SudoGest
Nasal Decongestant

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)
use by expiration date on package

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

SUDOGEST
pseudoephedrine hydrochloride tablet, film coated

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-5125-46	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/07/1984	10/31/2021
2	NDC:0904-5125-59	1 in 1 CARTON	12/07/1984	04/11/2021
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/07/1984	10/31/2021

Labeler - Major Pharmaceuticals (191427277)

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

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

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

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

Revised: 3/2022

Document Id: be8259b6-e2a1-4f10-8793-7f9099e12ac2

Set id: cfb1e96c-0580-ca73-70e4-75e07140ad43

Version: 15

Effective Time: 20220328

Major Pharmaceuticals

SudoGestNasal Decongestant