Nasal Decongestant PE by Meijer Distribution Inc / LNK International, Inc. Meijer 44-453

Nasal Decongestant PE by

Drug Labeling and Warnings

Nasal Decongestant PE by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hcl tablet 
Meijer Distribution 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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Meijer 44-453

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

Ask a doctor before use if you have

• diabetes
• heart disease
• high blood pressure
• 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 (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: do not use this product in children under 12 years of age 

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide 

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC: 41250-953-07

meijer™

Compare to SUDAFED PE® CONGESTION
active ingredient* 

Non-Drowsy

Nasal
Decongestant PE

Phenylephrine HCl 10 mg Nasal Decongestant

Maximum Strength

Sinus Pressure
Congestion

36 TABLETS

Actual Size

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

MEIJER PHARMACISTS RECOMMENDED
MONEY BACK GUARANTEE

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® CONGESTION.
50844     ORG031345307

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

Meijer 44-453

NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-953
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: 41250-953-07	2 in 1 CARTON	01/14/2005	03/29/2020
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41250-953-23	4 in 1 CARTON	01/14/2005	03/29/2020
2		18 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	01/14/2005	03/29/2020

Labeler - Meijer Distribution Inc (006959555)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(41250-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(41250-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(41250-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(41250-953)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(41250-953)

Revised: 10/2017

Document Id: 2515c7e2-d9a1-4063-a59a-52171d5adbe7

34390-5

Set id: 74e8588f-aaa3-4ab6-9088-7d563b10def6

Version: 6

Effective Time: 20171026

 

Meijer Distribution Inc