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 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
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

PSEUDOEPHEDRINE HCL
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-211
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;112
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50844-211-14	500 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/29/2018	08/22/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/29/2018	08/22/2023

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

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

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

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

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

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

Revised: 8/2023

Document Id: 4a2db093-7ca7-4b2b-b6db-673635e58922

Set id: 5e5f0b4b-c7ef-4372-a48c-b19728b14c59

Version: 7

Effective Time: 20230823

L.N.K. International, Inc.