Texaclear Mold Mix Allergy Relief Liquid
FDA Label NDC 58809-219

12 label sections · Submitted to the FDA by Gm Pharmaceuticals, Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Texaclear Mold Mix Allergy Relief (NDC 58809-219). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Otc - Questions

→ Other

→ Package Label.principal Display Panel

Otc - Active Ingredient

Antigens 15X, 30X, 60X: Alternaria alt., Aspergillus fum., Aspergillus nig., Aureobasidium pul., Bipolaris sor., Boletus sat., Botrytis cin., Candida alb., Cladosporium clad., Epicoccum nig., Gibberella pul., Mucor plu., Rhodotorula muc., Saccharomyces cer., Trichophyton men., Ustilago may., Histaminum 30X, 60X HPUS. Herbal Drainage Remedies 5X: Baptisia tinctoria HPUS, Echinacea HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Urtica urens HPUS.

Otc - Purpose

Purpose: Mold allergy symptom relief*

Indications & Usage

Uses: Temporarily relieves sneezing, runny nose, itchy, watery eyes, and nasal congestion associated with mold.*

Warnings

Use only as directed. For sublingual use.

Otc - Stop Use

Stop use and ask a doctor if symptoms worsen or do not improve after 7 days.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:

shake well before use
adults 12 and older: 10-15 drops under the tongue 3 times daily.
consult a doctor for use in children under 12.

Other Safety Information

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Inactive Ingredient

Inactive ingredients: ethanol, purified water, vegetable glycerin

Otc - Questions

1-888-535-0305 or visit www.texaclear.com

Other

*Claims based on traditional homeopathic practice. Not accepted medical evidence. Not FDA evaluated.

* Please review the disclaimer below.

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