SUDOGEST- pseudoephedrine hydrochloride tablet, film coated

SudoGest by

Drug Labeling and Warnings

SudoGest by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/01/1994

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

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

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