ALLEREST PE- chlorpheniramine maleate and phenylephrine hydrochloride tablet

Allerest by

Drug Labeling and Warnings

Allerest by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	4 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
Starch, Corn (UNII: O8232NY3SJ)
Hypromelloses (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Mineral Oil (UNII: T5L8T28FGP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	1;2;T;7
Contains

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

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)