Your browser does not support JavaScript! NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]
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RxNorm Names

NASAL DECONGESTANT (pseudoephedrine hcl) tablet
[L.N.K. International, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 2 weeks after stoppin 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
  • high blood pressure
  • heart disease
  • 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 yearstake 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours 
children under 6 yearsdo not use this product in children
under 6 years of age 

Other information

  • store at 25ºC (77º); 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 50844-112-08

*Compare to the active ingredient in Sudafed® Congestion

Non-Drowsy / Maximum Strength
Nasal Decongestant
Pseudoephedrine HCl 30 mg

Relieves:

  • Nasal & Sinus Congestion
  • Sinus Pressure

24 Tablets

QUALITY PLUS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
50844        REV0712L11208

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

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

Quality Plus 44-112

Qualty Plus 44-112

NASAL DECONGESTANT 
pseudoephedrine hcl tablet
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 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 44;112
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-112-151 in 1 CARTON
150 in 1 BLISTER PACK
2NDC:50844-112-082 in 1 CARTON
212 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)

Revised: 02/2013
Document Id: 988d2c49-7313-4526-bce4-b60a6641351a
Set id: f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5
Version: 1
Effective Time: 20130219
 
L.N.K. International, Inc.

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