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Name:Nasal Decongestant Pe
Manufacturer:Woonsocket Prescription Center,incorporated
Category:Over-the-counter (OTC) Marketed Drugs


CVS 44-453

NASAL DECONGESTANT PE - phenylephrine hydrochloride tablet, film coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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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CVS 44-453

Active ingredient(s)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Use(s)

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

  • temporarily relieves 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

  • 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 right away. (1-800-222-1222)

Directions

  • adults and children 12 years and over: take 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°-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 carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions

1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional pakaging may also be available.

CVS®

pharmacy

NDC 59779-453-07

Compare to the active

ingredient in Sudafed PE®*

See new dosing directions

Non-Drowsy

NASAL

DECONGESTANT PE

PHENYLEPHRINE HCl TABLETS

NASAL DECONGESTANT

Does not contain Pseudoephedrine

Nasal & Sinus Congestion

Sinus Pressure

36 TABLETS 10 mg EACH

36 DOSES

1 Pill/Dose

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

50844     ORG081045307

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2011 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

Product Packaging

Product Packaging


NASAL DECONGESTANT PE 
phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-453
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
DEXTROSE MONOHYDRATE  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
CARBOXYMETHYLCELLULOSE SODIUM  
TITANIUM DIOXIDE  
Product Characteristics
Color RED Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 44;453
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-453-07 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 36 TABLET, FILM COATED (36 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-453-07)
2 NDC:59779-453-44 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 18 TABLET, FILM COATED (18 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-453-44)

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

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 02/2011 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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