FDA.reportPublic FDA data

BHI Back

Manufacturer
MediNatura Inc
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:21:17

Label at a glance#

ProductBHI Back
Active ingredientAMMONIUM CHLORIDE, MATRICARIA RECUTITA, CITRULLUS COLOCYNTHIS FRUIT PULP, GELSEMIUM SEMPERVIRENS ROOT, PSEUDOGNAPHALIUM OBTUSIFOLIUM, TOXICODENDRON PUBESCENS LEAF
Label structure8 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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 INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Back Pain Relief Tablets

Relieves:

• Back Pain

• Leg & Hip Pain

• Muscle Spasm

USES

INDICATIONS & USAGE SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BHI Back.jpgBHI Back.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1007-2BHI Back100 in 1 BOTTLETABLET1004
62795-1007-3BHI Back1 in 1 CARTONTABLET14
62795-1007-3BHI Back100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1007BHI BACK (AMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAF) TABLET [MEDINATURA INC]4Current NDC, Legacy NDC, 3 package rows20230524_aa622a5b-16de-4098-9c3f-d7569f7d2c2f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1007-2EA - Each62795-10077ad988ac-fb01-4488-9a29-547d53401d8512015-10-02
62795-1007-3EA - Each62795-100779905c80-e9d9-4b36-a686-e5967960a30512023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMMONIUM CHLORIDEACTIVE INGREDIENT01Q9PC255D1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE INGREDIENT36XQ854NWW1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
AMMONIUM CATIONACTIVE MOIETY54S68520I41
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE MOIETY36XQ854NWW1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-100762795-1007-3, 62795-1007-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM CHLORIDE01Q9PC255DACTIM
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM36XQ854NWWACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BHI BackAMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAFMediNatura Incaa622a5b-16de-4098-9c3f-d7569f7d2c2f2023-05-23WarningsExact identifier
ndc (package): 62795-1007-2
ndc (package): 62795-1007-3
ndc (product): 62795-1007
ndc11 (package): 62795100702
ndc11 (package): 62795100703
spl id: af2b8787-5aee-4b15-afe6-65f1beaa0201
spl set id: aa622a5b-16de-4098-9c3f-d7569f7d2c2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.