SUPHEDRINE PE- phenylephrine hydrochloride tablet, coated 
GREAT LAKES WHOLESALE, MARKETING, & SALES, 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.

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Healthcare 44-453

Active ingredients (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

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

When using this product

 do not exceed recommended dose

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

Other information

Inactive ingredients

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

Questions or comments?

Call  1-888-287-1915

Principal display panel

HEALTHCARE
NDC 64092-802-18

Suphedrine PE
Maximum Strength
Phenylephrine HCl 10 mg
Nasal Decongestant

Non-Drowsy

Pseudoephedrine FREE

Relieves:
• Nasal & Sinus Congestion due to Colds & Allergies

*Compare to the active ingredient in Sudafed PE®

18 TABLETS

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®.
50844       REV1111F45344

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

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

Healthcare 44-453

Healthcare 44-453

SUPHEDRINE PE 
phenylephrine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-802
Route of Administration ORAL DEA Schedule     
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)  
CALCIUM PHOSPHATE, DIBASIC, 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)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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:64092-802-18 1 in 1 CARTON
1 18 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 - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(64092-802, 64092-802)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(64092-802, 64092-802)

Revised: 11/2012
Document Id: bb5626c0-ab89-4ea7-9891-45f7df9ee3be
Set id: 0b93ed6b-8a45-4f7e-b092-4465f99a2df5
Version: 1
Effective Time: 20121116
 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.