SPL v10
SPL
SPL Set ID e9e22991-48a0-4e66-bd6f-267f3e8badd6
Route
ORAL
Published
Effective Date 2016-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_C])
Inactive Ingredients
Gelatin Lactose Magnesium Stearate Starch, Potato Talc

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-07-01

Description

Arnica montana 6C HPUS


Medication Information

Warnings and Precautions

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

Indications and 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.

Dosage and 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
Description

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

Section 44425-7

store in a cool and dry place

Section 50565-1

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

Section 50566-9

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
Section 51727-6

Gelatin, lactose, magnesium stearate, potato starch, talc

Section 51945-4

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.

Section 53413-1

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

Section 53414-9

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

Section 55105-1

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.

Section 55106-9

Arnica montana 6C HPUS


Structured Label Content

Indications and Usage (34067-9)

 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.

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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

Description (34089-3)

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

Section 44425-7 (44425-7)

store in a cool and dry place

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 51727-6 (51727-6)

Gelatin, lactose, magnesium stearate, potato starch, talc

Section 51945-4 (51945-4)

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.

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

Arnica montana 6C HPUS


Advanced Ingredient Data


Raw Label Data

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