Drug Facts

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

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 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

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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

Questions or comments?

(800) 616-2471

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

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

Pseudoephedrine Hydrochloride

PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-4546(NDC:0904-6728)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	CPC
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50090-4546-0	24 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019
2	NDC:50090-4546-3	12 in 1 BOTTLE; Type 0: Not a Combination Product	09/27/2019
3	NDC:50090-4546-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019
4	NDC:50090-4546-4	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019
5	NDC:50090-4546-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/26/2019

Labeler - A-S Medication Solutions (830016429)