Otc - Purpose
Controls shakes, tremors, twitches and muscle spasms
Tremorsoothe
FDA Label NDC 68703-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands, Inc for the product Tremorsoothe (NDC 68703-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients: Each tablet contains equal parts of: Agaricus musc(6C) (HPUS), Mag phos (8X) (HPUS), Stramonium (6C) (HPUS), Tarentula hisp (6C) (HPUS)
Indications & Usage
Uses: Homeopathic remedy for tremors, shakes and spontaneous nerve spasms.
Warnings
Warnings:If symptoms persist or worsen, consult a healthcare professional.
Otc - Pregnancy Or Breast Feeding
If pregnant of breastfeeding, ask health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away
Dosage & 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 instruction: Dosage may be repeat every 30 minutes if needed during acute episodes.
Inactive Ingredient
Inactive Ingredients: Acacia gum, lactose, magnesium stearate, starch, sucrose
Information For Patients
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, Fl 33487
Phone:+1.877.289.1235
International:+1.561.999.8857
Contains no artificial flavors or artificial colors. No gluten added.
Storage And Handling
Tamper resistant for your protection. Use only if safety seal is intact
Package Label.Principal Display Panel
Bottle Label (Tso001)
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