BHI Back: Homeopathic Product Information

BHI BACK- ammonium chloride, matricaria recutita, citrullus colocynthis fruit pulp, gelsemium sempervirens root, pseudognaphalium obtusifolium and toxicodendron pubescens leaf tablet
MediNatura Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENT

Each tablet contains: Ammonium muriaticum 6X, *Chamomilla 10X, *Colocynthis 5X, *Gelsemium sempervirens 6X, *Gnaphalium polycephalum 5X, *Rhus toxicodendron 8X 50 mg each.

*Natural Ingredients

INACTIVE INGREDIENT

Inactive Ingredients: **Dextrose, ** Lactose, Magnesium Stearate, **Maltodextrin
**contains one or more of these ingredients.

PURPOSE

Back Pain Relief Tablets

Relieves:

• Back Pain

• Leg & Hip Pain

• Muscle Spasm

USES

For the temporary relief of minor back pain, leg & hip pain, muscle spasm

DIRECTIONS

At first sign of symptoms:

Adults and children 12 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage.

Standard dosage: Adults and children 12 years and older: take 1-2 tablets 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 12, consult your health professional.

Allow tablets to dissolve completely in the mouth, do not swallow.

WARNINGS

Warnings: If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to BHI Back or any of its ingredients exists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

BHI BACK ammonium chloride, matricaria recutita,citrullus colocynthis fruit pulp, pseudognaphalium obtusifolium, and toxicodendron pubescens leaf tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1007 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIUM CHLORIDE (AMMONIUM CATION) AMMONIUM CATION 6 [hp_X] MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 10 [hp_X] CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 5 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 5 [hp_X] TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 8 [hp_X]

Inactive Ingredients Ingredient Name Strength LACTOSE MAGNESIUM STEARATE DEXTROSE MALTODEXTRIN

Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Leafman Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62795-1007-3 1 BOTTLE in 1 CARTON contains a BOTTLE 1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (62795-1007-3) 2 NDC:62795-1007-2 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/30/2014

Labeler — MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Operations
MediNatura Inc		102783016	manufacture (62795-1007)

Revised: 05/2023 MediNatura Inc