PSEUDOEPHEDRINE HCL tablet, film coated

Pseudoephedrine HCl by

Drug Labeling and Warnings

Pseudoephedrine HCl by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., 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 and 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 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 children12 years 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 under 6 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)
• use by expiration date on package
  

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?

1-800-426-9391

Principal Display Panel

NDC: 50844-211-14

*Compare to active ingredient in
Sudafed® Congestion

Maximum Strength
Pseudoephedrine HCl
30 mg
Nasal Decongestant

Nasal & Sinus Congestion
* Non-Drowsy
Sinus Pressure

500 Tablets

Rx
For Pharmacist
Dispensing Only
NOT FOR
RETAIL SALE

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      ORG071211214

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge NY 11788 USA

Quality Plus 44-112

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HCL 
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-211
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (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: 50844-211-14	500 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/29/2018

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(50844-211)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(50844-211)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-211)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50844-211)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(50844-211)