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Name:Nasal Decongestant Penon Drowsy
Manufacturer:Publix Super Markets Inc
Category:Over-the-counter (OTC) Marketed Drugs


Publix Super Markets, Inc. Nasal Decongestant PE Drug Facts

NASAL DECONGESTANT PE NON DROWSY - phenylephrine hydrochloride tablet 
Publix Super Markets Inc

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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Publix Super Markets, Inc. Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine hydrochloride 10 mg

Purpose

Nasal decongestant

Uses

  • 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or are accompanied by 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 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, dibasic calcium phosphate, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Principal Display Panel

See New Dosing Directions

Non-Drowsy

Nasal Decongestant PE

Phenylephrine HCl Tablets, 10mg

Nasal & Sinus Congestion

Sinus Pressure

Maximum Strength

Aspirin-Free

One Tablet Dose

Actual Size

Compare to the Active Ingredient in Sudafed PE®

Nasal Decongestant PE Carton

Nasal Decongestant PE Carton


NASAL DECONGESTANT PE  NON DROWSY
phenylephrine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-094
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
CARNAUBA WAX  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
SILICON DIOXIDE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color RED Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L7
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56062-094-23 3 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 24 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (56062-094-23)
2 NDC:56062-094-89 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 18 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (56062-094-89)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/10/2005

Labeler - Publix Super Markets Inc (006922009)

Revised: 07/2009 Publix Super Markets Inc



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


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