NativeRemedies® TremorSoothe™ Tablets

Manufacturer
Silver Star Brands | OHM Pharma, Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:29:58

Label at a glance#

ProductTremorSoothe
Active ingredientAMANITA MUSCARIA FRUITING BODY, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, LYCOSA TARANTULA, DATURA STRAMONIUM
Label structure11 sections

Indications and uses

Uses*: Homeopathic remedy for temporary relief of dizziness and nausea. *Clais based on traditional homeopatchi practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Directions: For all ages: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. For all ages: Take 2 tablets 3 times daily until symptoms subside. Special instructions: Dosage may be repeated every 30 minutes if needed during acute episodes.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Each tablet contains equal parts of Agaricus musc 6C, Mag phos 8X, Stramonium 6C, Tarentula hisp 6C.

Uses*:

INDICATIONS & USAGE SECTION

Uses*: Homeopathic remedy for temporary relief of dizziness and nausea.

*Clais based on traditional homeopatchi practice, not accepted medical evidence. Not FDA evaluated.

Uses*:

INDICATIONS & USAGE SECTION

Uses*:Homeopathic remedy for temporary relief of dizziness and nausea.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: For all ages: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. For all ages: Take 2 tablets 3 times daily until symptoms subside.

Special instructions: Dosage may be repeated every 30 minutes if needed during acute episodes.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added. Lactose-free.

Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Magnesium stearate, Maltodextrin, Sucrose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication our of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - PURPOSE SECTION

Controls shakes, tremors, twitches & muscle spasms*

*Claims based on traditional homeopathic practice, not acceptd medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TremorSoothe LabelTremorSoothe Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-352-802023-03-01C16284748780-1f386c64a-39f7-0266-e053-dadaa90a7c1aNativeRemedies® TremorSoothe™ Tablets
68703-352-802023-01-30C16284748780-1f386c64a-39f7-0266-e053-dadaa90a7c1aNativeRemedies® TremorSoothe™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-352-80TremorSoothe189 in 1 BOTTLE, GLASSTABLET1895

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-352TREMORSOOTHE (AGARICUS MUSC, MAG PHOS, STRAMONIUM, TARENTULA HISP) TABLET [SILVER STAR BRANDS]5Current NDC, Legacy NDC, 1 package rows20250103_b6c17f42-6a08-6f89-e053-2a95a90aafaa.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-35268703-352-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
TremorSootheAGARICUS MUSC, MAG PHOS, STRAMONIUM, TARENTULA HISPSilver Star Brandsb6c17f42-6a08-6f89-e053-2a95a90aafaa2025-01-01WarningsExact identifier
ndc (package): 68703-352-80
ndc (product): 68703-352
ndc11 (package): 68703035280
spl id: 2ab1287c-c753-6a71-e063-6394a90a1cdd
spl set id: b6c17f42-6a08-6f89-e053-2a95a90aafaa

Reported adverse events (FAERS/openFDA)#

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