R257

R257
SPL v1
SPL
SPL Set ID 38b89b32-4915-487d-8b2d-250123487b15
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudognaphalium Obtusifolium Whole (3 [hp_X]) Berberis Vulgaris Root Bark (4 [hp_X]) Black Cohosh (6 [hp_X]) Cinchona Officinalis Bark (8 [hp_X]) Rhododendron Tomentosum Leafy Twig (10 [hp_X]) Ranunculus Bulbosus Whole (12 [hp_X]) Horse Chestnut (30 [hp_X]) Borate Ion Citrullus Colocynthis Fruit Pulp Cupric Cation Carbonate Ion Picric Acid Pulsatilla Montana Whole Claviceps Purpurea Sclerotium Silicon Dioxide Ammonium Cation Bos Taurus Bone Marrow Bovine Type Ii Collagen (tracheal Cartilage) Bos Taurus Intervertebral Disc Sus Scrofa Adrenal Gland Silver Anhydrous Dibasic Calcium Phosphate Mercuric Oxide Sepia Officinalis Juice Zinc Gonorrheal Urethral Secretion Human Sulfur
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Gnaphalium polycephalum 3X Berberis vurgaris 4X Cimicifuga racemosa 4X Cinchona officinalis 4X Ledum palustre 4X Ranunculus bulbosus 4X Aesculus hippocastanum 6X Borax 6X Colocynthis 6X Cuprum aceticum 6X Kali carbonicum 6X Picricum acidum 6X Pulsatilla 6X Secale cornutum 6X Silicea 6X Ammonium muriaticum 8X Bone marrow 8X Cartilage 8X Intervertebral disc 8X Adrenal 10X Argentum metallicum 10X Calcarea phosphorica 10X Mercurius praecipitatus ruber 10X Sepia 10X Zincum metallicum 10X Medorrhinum 12X Sulphur 30X


Medication Information

Description

Gnaphalium polycephalum 3X Berberis vurgaris 4X Cimicifuga racemosa 4X Cinchona officinalis 4X Ledum palustre 4X Ranunculus bulbosus 4X Aesculus hippocastanum 6X Borax 6X Colocynthis 6X Cuprum aceticum 6X Kali carbonicum 6X Picricum acidum 6X Pulsatilla 6X Secale cornutum 6X Silicea 6X Ammonium muriaticum 8X Bone marrow 8X Cartilage 8X Intervertebral disc 8X Adrenal 10X Argentum metallicum 10X Calcarea phosphorica 10X Mercurius praecipitatus ruber 10X Sepia 10X Zincum metallicum 10X Medorrhinum 12X Sulphur 30X

Label

Est 1985

Professional Formulas

Complementary Health

Ledum Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

In case of overdose, get medical help or contact a poison control center right away.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of mild joint, muscle, or back pain, stiffness, or tenderness.*

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients

Gnaphalium polycephalum 3X

Berberis vurgaris 4X

Cimicifuga racemosa 4X

Cinchona officinalis 4X

Ledum palustre 4X

Ranunculus bulbosus 4X

Aesculus hippocastanum 6X

Borax 6X

Colocynthis 6X

Cuprum aceticum 6X

Kali carbonicum 6X

Picricum acidum 6X

Pulsatilla 6X

Secale cornutum 6X

Silicea 6X

Ammonium muriaticum 8X

Bone marrow 8X

Cartilage 8X

Intervertebral disc 8X

Adrenal 10X

Argentum metallicum 10X

Calcarea phosphorica 10X

Mercurius praecipitatus ruber 10X

Sepia 10X

Zincum metallicum 10X

Medorrhinum 12X

Sulphur 30X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Ledum Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings (WARNINGS)

In case of overdose, get medical help or contact a poison control center right away.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of mild joint, muscle, or back pain, stiffness, or tenderness.*

Other Information (OTHER INFORMATION)

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients (ACTIVE INGREDIENTS)

Gnaphalium polycephalum 3X

Berberis vurgaris 4X

Cimicifuga racemosa 4X

Cinchona officinalis 4X

Ledum palustre 4X

Ranunculus bulbosus 4X

Aesculus hippocastanum 6X

Borax 6X

Colocynthis 6X

Cuprum aceticum 6X

Kali carbonicum 6X

Picricum acidum 6X

Pulsatilla 6X

Secale cornutum 6X

Silicea 6X

Ammonium muriaticum 8X

Bone marrow 8X

Cartilage 8X

Intervertebral disc 8X

Adrenal 10X

Argentum metallicum 10X

Calcarea phosphorica 10X

Mercurius praecipitatus ruber 10X

Sepia 10X

Zincum metallicum 10X

Medorrhinum 12X

Sulphur 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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