SUDOGEST- pseudoephedrine hcl tablet, film coated

SudoGest by

Drug Labeling and Warnings

SudoGest by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 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 2 for 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
• diabetes
• thyroid disease
• high blood pressure
• 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 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 andchildren 12years and older:

  take 2 tablets every 4 to; 6 hours; do not take; more than 8 tablets in 24; hours;

• children ages6 to 12 years:

  take 1 tablet every 4 to 6; hours; do not take more; than 4 tablets in 24; hours;

• children under6 years:

  do not use this product; in children under 6 years; of age;

Other information

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

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments?

(800) 616-2471

Principal Display Panel

NDC: 7105-133-24
*Compare to the active ingredient in Sudafed® Congestion

FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.

Non-Drowsy

SudoGest™
NASAL DECONGESTANT
Pseudoephedrine Hydrochloride 30 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

24 TABLETS

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
50844         REV0712L11212

Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA          M-17
Rev. 08/13
Re-Order No. 700321

Relabeled By;
Proficient Rx LP
Thousand Oaks CA 91320

INGREDIENTS AND APPEARANCE

SUDOGEST 
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-133(NDC:0904-5053)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;112
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-133-24	1 in 1 CARTON	10/01/2018
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/25/1981

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(71205-133)