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

----------

BHI Back

KEEP OUT OF REACH OF CHIDREN

Keep this and all medications out of the reach of children.

INDICATIONS ANS USAGE

Relieves:

• Back Pain

• Leg & Hip Pain

• Muscle Spasm

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 healthcare professional should be consulted. Do not use if known sensitivity to Back or any

of its ingredients exists.

DOSAGE AND ADMINISTRATION

Directions: At first sign of symptoms: Adults and children 12 years and older: 1 tablet every 1/2 to 1 houruntil symptoms lessen, then continue with standard dosage.Do not exceed 12 tablets in 24 hours. Standard dosage:

Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

For children under 12, consult your healthcare provider.

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

ACTIVE INGREDIENT

Active Ingredients: 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 INGREDIENTS

Inactive Ingredients: Lactose, Magnesium stearate

PURPOSE

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

BHI Back.jpg

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

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50114-4263
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	8 [hp_X]
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF)	TOXICODENDRON PUBESCENS LEAF	8 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE
MAGNESIUM STEARATE

Product Characteristics
Color	white (Table)	Score	no score
Shape	ROUND (Tablet)	Size	9mm
Flavor		Imprint Code	BHI;O;M
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-4263-2	100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/30/2007	08/20/2014

Labeler - Heel Inc (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
Heel Inc		102783016	manufacture(50114-4263)

Revised: 8/2014

Document Id: 83c70a87-914d-4d60-aa14-fd9c3991ba2a

Set id: 3aacedcf-2e00-46ed-81d6-9a1500be7975

Version: 2

Effective Time: 20140819

Heel Inc