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

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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

www.cvs.com

1-800-shop-CVS

Product Packaging

NASAL DECONGESTANT PE
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	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
#	NDC	Package Description	Multilevel Packaging
1	59779-453-07	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		36 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (59779-453-07)
2	59779-453-44	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
2		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: 02/2011WOONSOCKET PRESCRIPTION CENTER,INCORPORATED