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Nasal Decongestant by L.N.K. International, Inc.

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-112

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Quality Plus 44-112

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 children
12 years and older 

take 2 tablets every 4 to 6 hours; do
not take more than 8 tablets in 24
hours 
children ages
6 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)
  • 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? 1-800-426-9391

Principal Display Panel

NDC 50844-112-22

*Compare to active ingredient in
Sudafed® Congestion

MAXIMUM STRENGTH NASAL
DECONGESTANT

Pseudoephedrine HCl 30 mg • NASAL DECONGESTANT

• NASAL & SINUS CONGESTION •
• SINUS PRESSURE •

48 Tablets

NON-DROWSY

ACTUAL SIZE

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

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Sudafed® Congestion.
50844      REV0712B11222

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

Quality Plus 44-112

NASAL DECONGESTANT 
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
TRIACETIN 
SILICON DIOXIDE 
FD&C RED NO. 40 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;112
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-112-224 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:50844-112-082 BLISTER PACK in 1 CARTON
212 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/1981
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-112)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-112)

 
L.N.K. International, Inc.

← See all Nasal Decongestant brands

Medically reviewed on Mar 4, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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