Histanaz
Histanaz is an FDA drug label for the active ingredient PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE manufactured by Capital Pharmaceutical, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260422.
- Generic name
- PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE
- Manufacturer
- Capital Pharmaceutical, LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 29978-129
- Application
- M012
- Label effective
- 20260422
About this product
Histanaz is an FDA-registered drug product whose active ingredient is PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE. It is labelled by Capital Pharmaceutical, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 29978-129, application M012, label effective 20260422. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE are most often described in connection with: temporarily relieves, symptoms due, common cold, hay fever, allergic rhinitis, upper respiratory, allergies nasal, congestion runny. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: nasal congestion runny nose itchy watery eyes itching of the nose and throat
Dosage & Administration
Directions: Do not exceed recommended dosage. Adults and Children 12 years of age and over: 1 tablet every 6/8 hours. Do not exceed 4 tablets in 24 hours. Children 6-12 years of age: 1/2 tablet every 6/8 hours. Do not exceed 2 tablets in 24 hours.
Warnings
Warnings Do not exceed recommended dosage. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
Frequently asked questions
What is Histanaz used for?
Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: nasal congestion runny nose itchy watery eyes itching of the nose and throat
Who makes Histanaz?
Capital Pharmaceutical, LLC is the labeler of record for Histanaz.
What form does Histanaz come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Histanaz prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Histanaz been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.