Progena
FDA Label NDC 62713-941

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 Progena (NDC 62713-941). 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:Anacardium orientale 30C, Calcarea phosphorica 30C, Carcinosin 30C, Iodium 30C, Stramonium 30C, Tarentula hispana 30C, Veratrum album 30C.

Otc - Purpose

Purpose:Formulated to temporarily help the body's ability to concentrate, remain focused, improve self-esteem and confidence, and lessen restlessness.

Indications & Usage

Use:This product is a Homeopathic Dilution formulated for the temporary relief of symptoms associated with Attention Deficit Disorders (with or without hyperactivity).

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:•Adults (20 and Older)take 15 drops under the tongue three times daily.•Teenagers (13-19 yrs.)take 15 drops under the tongue three times daily.•Children (12 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.progena.com

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