NASAL DECONGESTANT- phenylephrine hcl tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
L.N.K. International, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves sinus congestion and pressure
Authorization status:
OTC monograph final
Authorization number:
50844-263-44

NASAL DECONGESTANT- phenylephrine 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.

----------

Convenience Valet 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 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

Nas al

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 4 4 -4 53

NASAL DECONGESTANT

phenylephrine hcl tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 44-26 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

44;453

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:50 8 44-26 3-44 1 in 1 CARTON

0 8 /0 5/20 19

1

18 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 8 /0 5/20 19

L.N.K. International, Inc.

Labeler -

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

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(50 8 44-26 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(50 8 44-26 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(50 8 44-26 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(50 8 44-26 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(50 8 44-26 3)

Revised: 6/2020

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