OTC Labels

Over the Counter Medications

OTC Medication Information: Nasal Decongestant PE

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.

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 (1-800-222-1222) right away.

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 25ºC (77ºF); excursions permitted between 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

CVS®

pharmacy

Compare to the active ingredient in Sudafed PE®*

Non-Drowsy

NASAL

DECONGESTANT PE

PHENYLEPHRINE HCl TABLETS

NASAL DECONGESTANT

Does not contain Pseudoephedrine

Congestion

Sinus Pressure

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

50844 REV1111B45307

Distributed by: CVS/pharmacy, inc.

One CVS Drive, Woonsocket, RI 02895

© 2012 CVS/pharmacy

Product Packaging
(click image for full-size original)

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
CALCIUM PHOSPHATE, DIBASIC, 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: 01/2012 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED