Allergena
FDA Label NDC 62713-812

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meditrend, Inc. Dba Progena Professional Formulations for the product Allergena (NDC 62713-812). 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, otc - keep out of reach of children, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:Echinacea 3X HPUS; Drainage Remedies:Baptisia Tinctoria 3X HPUS, Hydrastis Canadensis 3X HPUS, Myrrha 3X HPUS, Nasturtium Aquaticum 3X HPUS, Phytolacca Decandra 3X HPUS, Trigonella Foenum-Graecum 3X; Dust Mite and House Dust Antigen 9X, 12X, 15X, 30X:Blatta Orientalis (Oriental Cockroach) HPUS, Dust Mite (D.Pteronyssinus, D. Farinae), Grain Dust (Barley, Corn, Millet, Oat, Rice, Wheat), House Dust (Mattress, Rug, Upholstery), Periplaneta Americana (American Cockroach) HPUS; Stannum Metallicum 12X HPUS.

Otc - Purpose

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.

Indications & Usage

Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.

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.

Warnings

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctor ifsymptoms worsen or do not improve after 5 days.
  • If pregnant or breast-feeding, consult a health professional before use.

Dosage & Administration

Directions:• Shake Well Before Use.• Adults (12 and Older)take 15 drops under the tongue three times daily.• Children (11 and Younger)take 6 drops under the tongue three times daily or as directed by your health care professional.• Consult a Physicianfor use in children under 12 years of age.

Other Safety Information

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

Inactive Ingredient

Inactive Ingredients:Demineralized water and 25% USP Ethanol.

Package Label.Principal Display Panel

Manufactured for Progena Professional Formulations
4820 Eubank Blvd. NE, ABQ, NM 87111, www.allergena.com

Image Of Label (Dustmite)

Image Of Label (Dustmite)

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