PSEUDOEPHEDRINE HCL- pseudoephedrine hcl tablet, film coated 
L.N.K. International, Inc.

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.

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Amerisource 44-112 Delisted

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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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 right away.

Directions

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

Other information

  • each tablet contains: calcium 15 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

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?

1-800-426-9391

Principal Display Panel

NDC 50844-211-14

*Compare to active ingredient in Sudafed® Sinus Congestion

Maximum Strength
Pseudoephedrine HCl
30 mg
Nasal Decongestant

• Nasal & Sinus Congestion
• Non-Drowsy
• Sinus Pressure

Actual Size

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 Johnson & Johnson Corporation, owner of the registered trademark Sudafed® Sinus Congestion.
50844     REV0619A11214

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

Amerisource 44-112

Amerisource 44-112

PSEUDOEPHEDRINE HCL 
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
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
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-211-14500 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/29/201808/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/201808/22/2023
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-211)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(50844-211)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(50844-211)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(50844-211)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-211)

Revised: 8/2023
 
L.N.K. International, Inc.