Allergena Texas Cedar Fever Tabs Tablet, Orally Disintegrating
FDA Label NDC 62713-993

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 Texas Cedar Fever Tabs (NDC 62713-993). 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, otc - keep out of reach of children, indications & usage, 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:Antigens 6X, 12X, 30X: **Seasonal Grasses, **Seasonal Trees, **Seasonal Weeds; Herbal Drainage Remedies: Baptisia tinctoria 3X HPUS, Myrrha 3X HUPS, Nasturtium aquaticum 3X HPUS, Phytolacca decandra 3X HPUS, Trigonella foenum-graecum 3X, Hydrastis canadensis 5X HPUS; Echinacea 3X HPUS.

Otc - Purpose

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

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.

Indications & Usage

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

Warnings

Warnings:

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

Dosage & Administration

Directions: •Adults (12 and Older) Chew and dissolve 1 tablet three times daily.  • Children (7-12) Chew and dissolve 1 tablet three times daily.  • Children (2-7) Chew and dissolve 1 tablet 2-3 times daily.  • Not recommended for children under 2 years old.  • Consult a Physician for use in children under 12 years of age.

Other Safety Information

Other Information:Safety sealed. Do not use if printed inner seal beneath the cap is missing or broken.

Inactive Ingredient

Inactive Ingredients:Croscarmellose Sodium, MagnesiumStearate, Microcrystalline Cellulose, Xylitol.

Package Label.Principal Display Panel

*www.allergena.com/disclaimer
**Standard antigen mix used inthes product is cross-reactive with Texas Cedar Fever tree, weed, and grass allergens. For a complete list of allergens visit  www.allergena.com

Manufactured for PROGENA Professional Formulations
4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

* Please review the disclaimer below.