PSEUDOEPHEDRINE HCL UNIT DOSE- pseudoephedrine hcl tablet, film coated

Pseudoephedrine HCl by

Drug Labeling and Warnings

Pseudoephedrine HCl by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. 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 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
• diabetes
• thyroid disease
• high blood pressure
• difficulty in urination due to enlargement of the prostate gland
  

When using this product

do not exceed recommended dosage.

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 (1-800-222-1222) right away.

Directions

• adults and children 12 years and over: take 2 tablets every 4 to 6 hours; do not take more than 8 ; tablets in 24 hours
• children ages 6 to 11 years: take 1 tablet every 4 to 6 hours; do not take more than 4 ; tablets in 24 hours
• children under 6 years: do not use

Other information

• each tablet contains: calcium 15 mg
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
•  see end flap for expiration date and lot number
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC: 0904-6990-61

Unit Dose

PSEUDOEPHEDRINE HCl

NASAL DECONGESTANT

30 mg

100 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844         REV0619A11212

Distributed by
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Rev. 09/19      M-17     Re-order No. 701183

Major 44-112

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HCL  UNIT DOSE
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6990
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)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

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: 0904-6990-61	10 in 1 CARTON	08/12/2019
1		10 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	08/12/2019

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0904-6990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0904-6990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0904-6990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0904-6990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0904-6990)