SINUS DECONGESTION- pseudoephedrine hcl tablet, film coated

Sinus Decongestion by

Drug Labeling and Warnings

Sinus Decongestion by is a Otc medication manufactured, distributed, or labeled by Kroger Company, 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 an MAOI, ask a doctor or pharmacist before taking this product.   

Ask a doctor before use if you have

• heart disease
• diabetes
• thyroid disease
• high blood pressure
• 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
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

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?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of SUDAFED® SINUS CONGESTION *See bottom panel

Kroger®

NDC: 30142-641-22

Maximum Strength
Sinus Decongestion
Pseudoephedrine
Hydrochloride Tablets
Nasal Decongestant

NON-DROWSY

RELIEVES:
Nasal & Sinus Congestion
Sinus Pressure

actual
size

48 TABLETS
30 mg EACH

OUR PHARMACIST RECOMMENDED

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

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
FOR MORE PRODUCT INFORMATION, SCAN UPC
USING YOUR KROGER APP OR CALL 800-632-6900

*Sudafed® is a registered trademark of
Johnson & Johnson Corporation, New Brunswick, NJ
08933. Johnson & Johnson Corporation is not
affiliated with The Kroger Co. or this product.

Our Brands. Our Guarantee.
Like It or Your Money Back.
www.kroger.com

50844    ORG061911222

Kroger 44-112

INGREDIENTS AND APPEARANCE

SINUS DECONGESTION 
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-641
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)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-641-08	1 in 1 CARTON	04/13/2021
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 30142-641-22	2 in 1 CARTON	04/13/2021
2		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/13/2021

Labeler - Kroger Company (006999528)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(30142-641)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(30142-641) , pack(30142-641)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(30142-641)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(30142-641)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(30142-641)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(30142-641)