NASAL DECONGESTANT PE- phenylephrine hcl tablet, film coated 
Strategic Sourcing Services LLC

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Sunmark 44-453

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

  • 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 right away.

Directions

Other information

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?

1-800-426-9391

Principal display panel

sunmark®

COMPARE TO SUDAFED PE® CONGESTION ACTIVE INGREDIENT*
NDC 70677-0109-1

nasal decongestant PE
PHENYLEPHRINE HCl 10 mg
Nasal Decongestant
Maximum Strength

Sinus Pressure,
Sinus & Nasal Congestion
NON-DROWSY

actual size
18 TABLETS

McKESSON
Distributed by McKesson Corporation
6555 State Highway 161
Irving, TX 75039
www.mckesson.com

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Congestion.
50844     ORG011845344

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

44-453

44-453



NASAL DECONGESTANT PE 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0109
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)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-0109-11 in 1 CARTON07/29/202008/03/2024
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/29/202008/03/2024
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(70677-0109) , pack(70677-0109)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(70677-0109)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(70677-0109)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(70677-0109)

Revised: 12/2023
Document Id: 7a956565-ff0a-498a-92cc-e529d47d28d9
Set id: 82f0830e-d609-4c53-bbe1-b41d62a8b644
Version: 7
Effective Time: 20231205
 
Strategic Sourcing Services LLC