Stahist Ad Tablet
FDA Label NDC 58407-625

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magna Pharmaceuticals, Inc. for the product Stahist Ad (NDC 58407-625). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use this product, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Rev. 10/11

Otc - Purpose

Active Ingredients
(in each immediate-release tablet)
Purpose
Chlorcyclizine HCl 25 mgAntihistamine
Pseudoephedrine HCl 60 mgNasal Decongestant

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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 ageConsult a doctor

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions Or Comments?

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

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

Principal Display Panel (25 mg/60 mg Tablet Carton)

Principal Display Panel (25 mg/60 mg Tablet Carton)

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