SUPHEDRINE PE - phenylephrine hcl tablet, film coated 
COSTCO WHOLESALE CORPORATION

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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Drug Facts

Active ingredient

(in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

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

When using this product

do not exceed the recommended dosage

Stop use and ask a doctor if

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

Other information

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

Product Label
SUPHEDRINE PE  
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-453
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63981-453-691 in 1 CARTON
1144 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/06/2004
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIBusiness Operations
L.N.K. International, Inc832867894MANUFACTURE

Revised: 9/2010
Document Id: 99fda970-386d-4147-b601-4bcf21a63b06
Set id: e6731360-a309-1652-6c43-5235076c18a4
Version: 2
Effective Time: 20100921
 
COSTCO WHOLESALE CORPORATION