Active ingredient

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
thyroid disease
heart disease
high blood pressure
trouble urinating due to enlargement of the 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 controlled room temperature 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

Principal display panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available

MAJOR®

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 0904-5125-59

SudoGest™

NASAL DECONGESTANT 60 mg

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

100 TABLETS

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

50844 Rev. 0807L11302

Distributed by Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA M-17

Repacked by H.J. Harkins Company, Inc.

Nipomo, CA 93444

Rev. 10/11 Re-order No. 700324

Product Packaging

SUDOGEST
pseudoephedrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52959-260(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
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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

#	Item Code	Package Description
Packaging
1	NDC:52959-260-00	100 in 1 BOTTLE, PLASTIC
2	NDC:52959-260-20	20 in 1 BOTTLE, PLASTIC
3	NDC:52959-260-24	24 in 1 BOTTLE, PLASTIC
4	NDC:52959-260-25	25 in 1 BOTTLE, PLASTIC
5	NDC:52959-260-30	30 in 1 BOTTLE, PLASTIC
6	NDC:52959-260-40	40 in 1 BOTTLE, PLASTIC
7	NDC:52959-260-60	60 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	10/01/1994

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - H.J. Harkins Company, Inc. (147681894)

Name	Address	ID/FEI	Business Operations
Establishment
H.J. Harkins Company, Inc.		147681894	repack, relabel

SudoGestNasal Decongestant