Product Dossier: ASMAZOL®

1. Product Identification

• Product Name: Asmazol®
• Type: Herbal Phytotherapeutic Syrup
• Origin: Brazil
• Primary Use: Natural respiratory support; bronchial inflammation relief
• Status: Dietary Supplement (Non-pharmaceutical classification in Brazil)

2. Botanical Composition

• Active Plant Source: Dicksonia sellowiana (commonly known as Xaxim)
• Plant Part Used: Leaves
• Extraction Type: Aqueous or hydroalcoholic extraction (traditional maceration method)
• Supplemental Components: Often includes Vitamin C, natural preservatives, glycerol-based carriers

3. Indications and Use

Therapeutic Indications:

• Asthma (mild to moderate)
• Chronic Bronchitis
• Rhinitis & Sinusitis
• Allergic Respiratory Inflammation
• Influenza-associated chest congestion

Target Populations:

• Suitable for pediatric to geriatric use (dosage by age group)
• May be used in chronic and acute respiratory support protocols

4. Dosage & Administration

• Administration Route: Oral
• Form: Liquid syrup
• Presentation: 200 mL bottle (PET grade with safety cap)

5. Mechanism of Action (Traditional Use-Based)

• Exhibits anti-inflammatory and bronchodilatory effects
• Inhibits mucus overproduction in bronchial pathways
• Supports epithelial healing in the upper and lower respiratory tract
• Provides immune support via vitamin C content

6. Contraindications & Warnings

• Not recommended for use during pregnancy or breastfeeding without medical supervision
• Patients with known hypersensitivity to fern species or glycerol should avoid use
• Not a substitute for corticosteroids or beta-agonists in severe asthma cases
• Store below 25°C, out of direct sunlight. Shake well before use.

7. Clinical and Market Data

• Years on Market: >20 years in Brazil
• Reported Success Rate: >90% symptomatic improvement per manufacturer (not peer-reviewed)
• Scientific Research: Limited clinical trials; product based on ethnobotanical traditions
• Market Category: Natural health product, OTC supplement in Brazil

8. Regulatory Information

• ANVISA Status: Exempt from registration under RDC 02/2007 (Brazil)
• Export Classification: Herbal supplement, non-therapeutic labeling for international markets
• Customs HS Code: 3004.90.99 (Plant-based respiratory remedies, non-scheduled)

9. Packaging & Logistics

• Primary Packaging: Amber PET bottle with tamper-evident cap
• Secondary Packaging: Boxed unit with instructions in Portuguese (English label available upon request)
• Units per Carton: 24 bottles
• Shelf Life: 24 months from date of manufacture
• Cold Chain: Not required

10. Manufacturer & Supply Chain

• Manufactured by: [Undisclosed – Private Label Partner in Brazil]
• Production Site: São Paulo State, Brazil
• Distributed by: Pan American Exports LLC / Distribuidora Farmacéutica Pan Americana S.A. de C.V.
• Quality Certifications: Internal GMP-equivalent production standards. No WHO-GMP or ISO.

11. Commercial Considerations

• MOQ (Export): 1,000 bottles (negotiable for pilot orders)
• Suggested Retail Price (Brazil): R$79–R$99 (≈ U$D 15–20)
• Target Markets: Latin America, Middle East, Caribbean, West Africa