FDA.reportPublic FDA data

BHI Spasm Pain Tablet

Manufacturer
MediNatura Inc
Effective date
2023-09-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:22:23

Label at a glance#

ProductBHI Spasm Pain
Active ingredientATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, CUPRIC SULFATE
Label structure7 sections

Dosage and administration

At first sign of symptoms: Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage.  Standard dosage: Adults and children 4 years and older: Take 1-2  tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 4, consult your health professional. Allow tablets to dissolve completely in the mouth, do not swallow.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains: Atropinum sulphuricum 6X, *Aconitum napellus 4X, *Bryonia alba 4X, *Colocynthis 4X, Cuprum sulphuricum 6X 60 mg each.

*Natural Ingredients

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:Dextrose,  Magnesium Stearate, Maltodextrin

PURPOSE

OTC - PURPOSE SECTION

Cramp/Spasm Relief Tablets

Relieves:

• Menstrual Cramps

• Abdominal Bloating

• Muscle Spasms

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

At first sign of symptoms: Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. 

Standard dosage: Adults and children 4 years and older: Take 1-2 tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours.

For children under 4, consult your health professional.

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

WARNINGS

WARNINGS SECTION

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 Spasm Pain 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 Spasm Pain Tablet.jpgBHI Spasm Pain Tablet.jpg

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1015-3BHI Spasm Pain1 in 1 CARTONTABLET15
62795-1015-3BHI Spasm Pain100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1015BHI SPASM PAIN (ATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, AND CUPRIC SULFATE) TABLET [MEDINATURA INC]5Current NDC, Legacy NDC, 2 package rows20230929_3e117ea6-bbb2-4b77-b3ce-01572e6d71c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1015-2EA - Each62795-101581610230-bb3b-4e7b-954a-74247e544f3a12015-10-02
62795-1015-3EA - Each62795-1015643f7254-6f1a-43b2-b399-fc8f2e867b0d12023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA51
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DT1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ATROPINEACTIVE MOIETY7C0697DR9I1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-101562795-1015-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPINE SULFATE03J5ZE7KA5ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
CUPRIC SULFATELRX7AJ16DTACTIM
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSEIY9XDZ35W2IACT

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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 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 Spasm PainATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, AND CUPRIC SULFATEMediNatura Inc3e117ea6-bbb2-4b77-b3ce-01572e6d71c12023-09-28WarningsExact identifier
ndc (package): 62795-1015-3
ndc (product): 62795-1015
ndc11 (package): 62795101503
spl id: 81de70ac-1a68-4608-a1e7-ca8aa6ef5b1b
spl set id: 3e117ea6-bbb2-4b77-b3ce-01572e6d71c1

Reported adverse events (FAERS/openFDA)#

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