Arnica montana pellet

Otc - active ingredient section

Arnica montana......6C HPUS

Otc - purpose section

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 section

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 section

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

Otc - stop use section

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

Otc - pregnancy or breast feeding section

If pregnant or breast feeding, consult a health professional.

Otc - keep out of reach of children section

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & administration section

Directions

  • adults and children over4 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 section

Store in a cool and dry place

Inactive ingredient section

Sucrose

Otc - questions section

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

Description section

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 section

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

Ingredients and appearance - Product information

Arnica montana pellet- Arnica montana

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 34666-091
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Arnica montana ( UNII: O80TY208ZW)( Arnica montana - UNII: O80TY208ZW ) 6 [hp_C]in 1

Inactive Ingredients

Ingredient Name Code
Sucrose ( UNII: C151H8M554)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 34666-091-50 150 in 1 BOTTLE, GLASS 2011/07/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved homeopathic USA 2011/07/01

Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV( 589914576)

Establishment

Name ID/FEI Business Operations
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV 589914576 manufacture( 34666-091)

Package label.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