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STAHIST AD

Magna Pharmaceuticals, Inc.

Stahist AD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients
(in each immediate-release tablet)
Purpose
Chlorcyclizine HCl 25 mg Antihistamine
Pseudoephedrine HCl 60 mg Nasal Decongestant

STAHIST AD Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes melitus
  • difficulty in urination due to enlargement of the prostate gland

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

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 1 tablet by mouth every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: ½ tablet by mouth every 6-8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor
Children under 6 years of age Consult a doctor

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions or Comments?

Call 1-888-206-5525 • www.magnaweb.com

Rev. 10/11

PRINCIPAL DISPLAY PANEL - 25 mg/60 mg Tablet Carton

NDC 58407-625-30

Antihistamine • Nasal Decongestant

Stahist AD

Each tablet contains:
Chlorcyclizine HCl 25 mg
Pseudoephedrine HCl 60 mg

MAGNA
Pharmaceuticals, Inc.
Louisville, KY 40299

30 Tablets

STAHIST AD

STAHIST AD

CHLORCYCLIZINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58407-625
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorcyclizine Hydrochloride Chlorcyclizine 25 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 60 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm M625 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:58407-625-01 1 in 1 BLISTER PACK
3 NDC:58407-625-06 6 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-12-20


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Be sure to consult your doctor before taking any medication!
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