FDA.reportPublic FDA data

T-Relief Pro Spasm

Manufacturer
MediNatura Inc
Effective date
2021-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:41:44

Label at a glance#

ProductT-Relief Pro Spasm
Active ingredientACONITUM NAPELLUS, AMANITA MUSCARIA FRUITING BODY, AMMONIUM BROMIDE, ATROPINE SULFATE, ATROPA BELLADONNA, MATRICARIA RECUTITA, CITRULLUS COLOCYNTHIS FRUIT PULP, CUPRIC SULFATE, GELSEMIUM SEMPERVIRENS ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PASSIFLORA INCARNATA FLOWERING TOP, VERATRUM ALBUM ROOT
Label structure8 sections

Indications and uses

For the temporary relief of minor: Menstrual Cramps • Abdominal Bloating • Muscle Spasms Leg Cramps

Dosage and administration

Adults and children 12 years and older : Chew 2 tablets every 4 hours, or use as directed by you health professional. Children 4 to 11 years : Chew 1-2 tablets every 4 hours,or as directed by your health professional . For children under 4 years , use as directed by your health professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains: *Aconitum napellus 6X 20%, *Agaricus muscarius 4X 5%, Ammonium bromatum 4X 10%, Atropinum sulphuricum 6X 10%, *Belladonna 6X 22%, *Chamomilla 2X 0.67%, *Colocynthis 3X 1.33%, Cuprum sulphuricum 6X 5%, *Gelsemium sempervirens 6X 10%, Magnesia phosphorica 6X 10%, *Passiflora incarnata 2X 5%, *Veratrum album 5X 1.33%.

*Natural Ingredients

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

USES

OTC - PURPOSE SECTION

For the temporary relief of minor: Menstrual Cramps • Abdominal Bloating • Muscle Spasms Leg Cramps

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: Chew 2 tablets every 4 hours, or use as directed by you health professional. Children 4 to 11 years: Chew 1-2 tablets every 4 hours,or as directed by your health professional . For children under 4 years, use as directed by your health professional.

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 T-ReliefTM Spasm 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

Indications

INDICATIONS & USAGE SECTION

Relieves

• Menstrual Cramps

• Abdominal Bloating

• Muscle Spasm

Leg Cramps

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

T-Relief Pro Spasm.jpgT-Relief Pro Spasm.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1040-2EA - Each62795-10407e5c6502-2651-4d67-9b06-4c21f5f1ce3d12018-12-13

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-104062795-1040-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
AMMONIUM BROMIDER0JB3224WSACTIB
ATROPINE SULFATE03J5ZE7KA5ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
CUPRIC SULFATELRX7AJ16DTACTIM
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

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
f166307e-e042-45bd-a6ae-7451092b34b5fdecf022-eb33-4717-849a-d70de226fbef2021-06-29WarningsExact identifier
spl id: f166307e-e042-45bd-a6ae-7451092b34b5
spl set id: fdecf022-eb33-4717-849a-d70de226fbef

Reported adverse events (FAERS/openFDA)#

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