SUPHEDRINE PE- phenylephrine hcl tablet, film coated

Suphedrine PE by

Drug Labeling and Warnings

Suphedrine PE by is a Otc medication manufactured, distributed, or labeled by COSTCO WHOLESALE CORPORATION, L.N.K. International, Inc., L.N.K. International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

When using this product

do not exceed the recommended dosage

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

• 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

• store at controlled room temperature 15°-30°C (59° to 86°F)
• 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 cardoxymethylcellulose, sodium citrate dihydrate, titanium dioxide

PRODUCT PACKAGING

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

INGREDIENTS AND APPEARANCE

SUPHEDRINE PE  
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63981-453
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)
Magnesium Stearate (UNII: 70097M6I30)
Maltodextrin (UNII: 7CVR7L4A2D)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Trisodium Citrate Dihydrate (UNII: B22547B95K)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	44;453
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63981-453-69	1 in 1 CARTON
1		144 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/06/2004

Labeler - COSTCO WHOLESALE CORPORATION (103391843)

Registrant - L.N.K. International, Inc. (832867837)

Establishment
Name	Address	ID/FEI	Business Operations
L.N.K. International, Inc		832867894	MANUFACTURE