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Allerest

Insight Pharmaceuticals

allerest PE PSEUDOEPHEDRINE FREE ANTIHISTAMINE / NASAL DECONGESTANT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each tablet)

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Purposes

Antihistamine

Nasal Decongestant

Allerest 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

Allerest

Allerest

Chlorpheniramine Maleate and Phenylephrine Hydrochloride TABLET

Product Information

Product Type Human otc drug label 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 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
Mineral Oil
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm 1;2;T;7 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 18 in 1 BLISTER PACK
2 NDC:63736-586-18 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-07-31


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Be sure to consult your doctor before taking any medication!
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