ARNICA RECOVERY- arnica montana tablet

Arnica Recovery by

Drug Labeling and Warnings

Arnica Recovery by is a Homeopathic medication manufactured, distributed, or labeled by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Arnica montana 6C HPUS

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.

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

PREGNANCY OR BREAST FEEDING

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

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

QUESTIONS

Questions or comments?  informacion@nartexlabs.com 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

DESCRIPTION

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.

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.

INGREDIENTS AND APPEARANCE

ARNICA RECOVERY 
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-010-60	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/01/2011
2	NDC: 34666-010-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2011

Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)

Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV		589914576	manufacture(34666-010)