Label: TREMORSOOTHE- agaricus musc, mag phos, stramonium, tarentula hisp tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68703-008-80 - Packager: Silver Star Brands, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 16, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
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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
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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:+1.561.999.8857Contains no artificial flavors or artificial colors. No gluten added.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TREMORSOOTHE
agaricus musc, mag phos, stramonium, tarentula hisp tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY 6 [hp_C] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 6 [hp_C] LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA 6 [hp_C] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) Product Characteristics Color white (White lactose tablets) Score no score Shape ROUND (Round white lactose tablets) Size 6mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68703-008-80 180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/30/2013 Labeler - Silver Star Brands, Inc (006070379) Establishment Name Address ID/FEI Business Operations King Bio 617901350 manufacture(68703-008) , api manufacture(68703-008)