NASAL DECONGESTANT- phenylephrine hcl tablet, film coated

Nasal Decongestant by

Drug Labeling and Warnings

Nasal Decongestant 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)

Phenylephrine HCl 10 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 (1-800-222-1222) right away.

Directions

• adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
• children under 12 years: ask a doctor
  

Other information

• 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, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-800-632-6900

Principal display panel

Kroger®

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

NDC: 30142-953-07

Non-Drowsy

Nasal Decongestant PE
Phenylephrine HCl 10 mg
Nasal Decongestant

MAXIMUM STRENGTH

Relieves:
Sinus Pressure
Nasal & Sinus Congestion

actual size

36
TABLETS

Our Pharmacists Recommend

*SUDAFED PE® CONGESTION 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.

50844   ORG011845307

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

QUALITY GUARANTEE
www.kroger.com

Kroger 44-453

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT 
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-953
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;453
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-953-07	2 in 1 CARTON	06/03/2019
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 30142-953-23	3 in 1 CARTON	06/03/2019
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 FINAL	part341	06/03/2019

Labeler - Kroger Company (006999528)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(30142-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(30142-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(30142-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(30142-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(30142-953)