NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet 
The Kroger Co.

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

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • 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 a 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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminium lake, FD&C yellow #6 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to the active ingredient of SUDAFED PE® NASAL DECONGESTANT *See bottom panel

NON- DROWSY

Nasal Decongestant PE

Phenylephrine HCl Tablets

Nasal Decongestant

Does Not Contain Pseudoephedrine

MAXIMUM STRENGTH

Relieves:

1 pill/dose

TABLETS 10 mg EACH

GLUTEN FREE

*Sudafed PE® is a registered trademark of McNeil Consumer Healthcare, Fort Washington, PA 19034. McNeil Consumer Healthcare is not affiliated with The Kroger Co. or this product.

EACH DOSE INDIVIDUALLY SEALED IN A BLISTER PACK . DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.Phenylephrine HCl 10 mg

Kroger Nasal Decongestant PE Tablets

NASAL DECONGESTANT PE 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-670
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code T234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-670-181 in 1 CARTON
118 in 1 BLISTER PACK
2NDC:30142-670-362 in 1 CARTON
218 in 1 BLISTER PACK
3NDC:30142-670-724 in 1 CARTON
318 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/02/2011
Labeler - The Kroger Co. (006999528)

Revised: 3/2014
Document Id: 3668ae5b-d3c3-4f47-ace9-c7a39f55e1ab
Set id: 8eec9d31-5f60-49bb-a427-e8163c9c8078
Version: 4
Effective Time: 20140318
 
The Kroger Co.