Suphedrine PE

Manufacturer: COSTCO WHOLESALE CORPORATION | L.N.K. International, Inc. | L.N.K. International, Inc
Effective date: 2010-09-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:26:11

Label at a glance#

ProductSuphedrine PE

Active ingredientPhenylephrine Hydrochloride

Label structure13 sections

Indications and uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relives sinus congestion and pressure

Dosage and administration

adults and children 12 years and over: 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

Storage and handling

store at controlled room temperature 15°-30°C (59° to 86°F) see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-800-774-2678

Websitewww.cvs.com

www.cvs.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relives sinus congestion and pressure

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

do not exceed the recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: 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

STORAGE AND HANDLING SECTION

store at controlled room temperature 15°-30°C (59° to 86°F)
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The product packaging shown below represents a sample of that currently in use. Additional packaging may aslo be available.

KIRKLAND

Signature™

COMPARE TO

SUDAFED PE™

active ingredient*

NDC 63981-453-69

ITEM # 111266

NON-DROWSY

SUPHEDRINE PE

Phenylephrine Hydrochloride 10 mg

Nasal & Sinus Decongestant Formula

Temporary Relief of:

√ Nasal Congestion

√ Sinus Pressure & Congestion

√ Hay Fever Symptoms

Actual Size

1 Pill Per Dose

144

TABLETS

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

50844 REV0810F45369

Manufactured by:

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For Costco Wholesale Corporation

P.O. Box 34535

Seattle, WA 98124-1535 USA

1-800-774-2678

www.cvs.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	2
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63981-453-69	2020-01-31	C162847	48780-1	9d75b9d0-2eb7-f424-e053-dadaa90a57ce	e6731360-a309-1652-6c43-5235076c18a4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63981-453-69	Suphedrine PE	1 in 1 CARTON	TABLET, FILM COATED	1		2
63981-453-69	Suphedrine PE	144 in 1 BLISTER PACK	TABLET, FILM COATED	144		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63981-453	SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION]	2	Legacy NDC, 2 package rows	20101020_e6731360-a309-1652-6c43-5235076c18a4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63981-453-69	EA - Each	63981-453	fffe4f5b-457b-4019-ba8c-dbe07d8fe089	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	2
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	2
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	2
Dextrose Monohydrate	INACTIVE INGREDIENT	LX22YL083G	2
Dibasic Calcium Phosphate Dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	2
Fd&c Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	2
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
Trisodium Citrate Dihydrate	INACTIVE INGREDIENT	B22547B95K	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Suphedrine PE
Phenylephrine HCl
Phenylephrine Hydrochloride
Phenylephrine
Croscarmellose Sodium
Dextrose Monohydrate
Dibasic Calcium Phosphate Dihydrate
Fd&c Red No. 40
Magnesium Stearate
Maltodextrin
Cellulose, Microcrystalline
Silicon Dioxide
Carboxymethylcellulose Sodium
Trisodium Citrate Dihydrate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63981-453	63981-453-69

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
Croscarmellose Sodium	M28OL1HH48	IACT
Dextrose Monohydrate	LX22YL083G	IACT
Dibasic Calcium Phosphate Dihydrate	O7TSZ97GEP	IACT
Fd&c Red No. 40	WZB9127XOA	IACT
Magnesium Stearate	70097M6I30	IACT
Maltodextrin	7CVR7L4A2D	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Carboxymethylcellulose Sodium	K679OBS311	IACT
Trisodium Citrate Dihydrate	B22547B95K	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 294 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / ORAL		1200 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION / INTRAVENOUS		3480 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / TOPICAL		186 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRASYNOVIAL	0.1 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET / SUBLINGUAL		51 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / RECTAL		773 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Dextrose Monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	INJECTION, EMULSION / INTRAVENOUS		188 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	FILM / SUBLINGUAL		7 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Dextrose Monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET, EXTENDED RELEASE / ORAL		92 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / BUCCAL	4 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	CLOTH / TOPICAL		2 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Trisodium Citrate Dihydrate	TRISODIUM CITRATE DIHYDRATE	B22547B95K	CONCENTRATE / ORAL		104 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
Fd&c Red No. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
99fda970-386d-4147-b601-4bcf21a63b06			e6731360-a309-1652-6c43-5235076c18a4	2010-09-21	Warnings	Exact identifier spl id: 99fda970-386d-4147-b601-4bcf21a63b06 spl set id: e6731360-a309-1652-6c43-5235076c18a4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.