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NDC 50844-0263-44 Nasal Decongestant 10 mg/1 Details

Nasal Decongestant 10 mg/1

Nasal Decongestant is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L.N.K. International, Inc.. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 50844-0263-44
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	50844-0263
Product ID	50844-263_ff40a863-2175-48aa-acf3-898ce1232396
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nasal Decongestant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	L.N.K. International, Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 50844-0263-44 (50844026344)

Pricing Information	N/A
NDC Package Code	50844-263-44
Billing NDC	50844026344
Package	1 BLISTER PACK in 1 CARTON (50844-263-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2019-08-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 47dffbb8-ff72-4dd3-83f2-703f896d1074 Details

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?

1-844-428-2538

Principal display panel

24/7

BY 7-Eleven™

Non-Drowsy

Maximum Strength

Nasal

Decongestant

Phenylephrine HCl/Nasal Decongestant

Relieves:

Sinus Pressure,

Sinus & Nasal

Congestion

compare to

Sudafed PE® Congestion

active ingredient*

18

TABLETS

Actual

Size

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of

the registered trademark Sudafed PE® Congestion.

50844 ORG011845344

DISTRIBUTED BY 7-ELEVEN, INC.

IRVING, TX 75063 WWW.7-ELEVEN.COM

Satisfaction Guaranteed 1-800-255-0711

CV 44-453

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT

phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-263
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50844-263-44	1 in 1 CARTON	08/05/2019	06/16/2024
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/05/2019	06/16/2024

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

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(50844-263)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(50844-263)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(50844-263)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(50844-263)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(50844-263)

Revised: 6/2022

Document Id: ff40a863-2175-48aa-acf3-898ce1232396

Set id: 47dffbb8-ff72-4dd3-83f2-703f896d1074

Version: 4

Effective Time: 20220616