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Name:Allerestpe
Manufacturer:Insight Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


allerest® PE PSEUDOEPHEDRINE FREE ANTIHISTAMINE / NASAL DECONGESTANT

ALLEREST PE - chlorpheniramine maleate and phenylephrine hydrochloride tablet 
Insight Pharmaceuticals

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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allerest® PE
PSEUDOEPHEDRINE FREE
ANTIHISTAMINE /
NASAL DECONGESTANT

Drug Facts

Active ingredients (in each tablet)

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Purposes

Antihistamine

Nasal Decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • nasal congestion
  • itching of nose or throat

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
  • glaucoma
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better in 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.

Directions

  • do not take more than 6 doses in 24 hours
adults and children 12 years and over take 1 tablet every 4 hours
children 6 years to under 12 years take 1/2 tablet every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years of age do not use

Inactive ingredients

Cellulose, Corn Starch, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Mineral Oil, Silicon Dioxide, Starch Glycolate, Steric Acid.

QUESTIONS?

Call 1-800-344-7239 or write to

Consumer Affairs at the address below.

Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 18 Tablet Blister Pack Carton

PSEUDOEPHEDRINE FREE

allerest® PE
Chlorpheniramine Maleate/Antihistamine • Phenylephrine HCl/Nasal Decongestant

Allergy & Sinus Relief

Relieves:

Sinus Congestion & Pressure
Sneezing, Itchy, Watery Eyes
Nasal Congestion

18 TABLETS

One Pill Per Dose

PRINCIPAL DISPLAY PANEL - 18 Tablet Blister Pack Carton

ALLEREST  PE
chlorpheniramine maleate and phenylephrine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-586
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 4 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn  
Hypromelloses  
Magnesium Stearate  
Mineral Oil  
Silicon Dioxide  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 1;2;T;7
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-586-18 1 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK
1 18 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BOX (63736-586-18)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/31/2009

Labeler - Insight Pharmaceuticals (176792315)

Revised: 01/2011 Insight Pharmaceuticals



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


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