Arnica Montana by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA pellet

Arnica Montana by

Drug Labeling and Warnings

Arnica Montana 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 the Food and Drug Adminsitration.  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 use 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.

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 over 4 years of age: take 3 pellets orally every 6 hours
• children under 4 years of age: consult a physician
• dissolve slowly in mouth

STORAGE AND HANDLING

Store in a cool and dry place

INACTIVE INGREDIENT

Sucrose

QUESTIONS

Questions or comments?informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

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 the neck seal is broken. 

This product is HOMEOPATHIC. Its claims 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 homeopathiy visit www.nartexlabsusa.com before using this product.

DESCRIPTION

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

PRINCIPAL DISPLAY PANEL

NDC: 34666-091-50

Arnica

Nartex

Pellets

For Sore muscles and bruises*

Homepthatic

*Based on Homeopathic Materia Medica

Arnica

Nartex

Directions

3 pellets orally every 6 hours**

**See Directions at the Back

150 pellets

INGREDIENTS AND APPEARANCE

ARNICA MONTANA 
arnica montana pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-091
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
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-091-50	150 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/01/2011

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(34666-091)