Arnica Recovery Tablet
FDA Label NDC 34666-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nartex Laboratorios Homeopaticos Sa De Cv for the product Arnica Recovery (NDC 34666-010). 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

Arnica montana 6C HPUS

Otc - Purpose

Arnica montana.......6C HPUS*..........Anti-inflammatory

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  C is a homeopathic dilution.  See www.nartexlabsusa.com for more information.  Active ingredients are preparaed in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Indications & Usage

 For the temporary relief of

  • sore muscles
  • bruises
  • sprains

    • as per homeopathic materia medica

    Product uses are based on Homeopathic Materia Medica.  These "Uses" have not been evaluated by teh Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.

Warnings

Do not use if you have an allergy or hypersensitivity to the components of the formula.

Otc - Stop Use

Stop and ask a physician if:

  • condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops

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.  If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:

  • adults and children 4 years of age and older: take 2 tablets every 6 hours, slowly dissolving in mouth
  • children under 4 years of age: consult a physician

Storage And Handling

store in a cool and dry place

Inactive Ingredient

Gelatin, lactose, magnesium stearate, potato starch, talc

Otc - Questions

Questions or comments?  [email protected] or call 1-877-248-1970 between 9am and 5pm CST

Description

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by Nartex.

Keep carton. It contains important information.

For you protection, this bottle has a seal around the neck.  Attention: do not use if hte neck seal is broken.

This product is HOMEOPATHIC.  Its claim and efficacy are based on homeopathic research and clinical experience.  This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs.  For more information on homeopathy visit www.nartexlabsusa.com before using this product.

Package Label.Principal Display Panel

NDC 34666-010-60

Arnica

Recovery Nartex

For Sore Muscles and Bruises*

Directions

2 tablets every 6 hours**

Homeopathic

60 Tablets

*Based on Homeopathic Materia Medica

**See directions at the Back.

Arnicatabletscarton (Arnicatabletscarton)

Arnicatabletscarton (Arnicatabletscarton)

* Please review the disclaimer below.