PSEUDOEPHEDRINE HYDROCHLORIDE tablet

Pseudoephedrine Hydrochloride by

Drug Labeling and Warnings

Pseudoephedrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

PURPOSE

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

• heart disease 
• high blood pressure
• thyroid disease 
• diabetes 
• 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 a 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

• take every 4-6 hours 
• do not take more than 4 doses in 24 hours

• adults & children 12 years & over:

  2 tablets

• children 6 to under 12 years:

  1 tablets

• children under 6 years:

  do not use

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
• use by expiration date on package

INACTIVE INGREDIENT

calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar, titanium dioxide

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Sudafed®.

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

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC: 0904-6727-60

Non Drowsy SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 30mg

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

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

Compare to the active ingredient in Sudafed® Congestion*

100 Tablets

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6727
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCROSE (UNII: C151H8M554)
KAOLIN (UNII: 24H4NWX5CO)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
GELATIN (UNII: 2G86QN327L)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1004
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6727-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/31/2019

Labeler - Major Pharmaceuticals (191427277)