Silicea by True Botanica, LLC SILICEA globule

Silicea by

Drug Labeling and Warnings

Silicea by is a Homeopathic medication manufactured, distributed, or labeled by True Botanica, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicea 30X, HPUS

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

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Use:

For temporary relief of headache, sensitivity to noise.  May also be used for standard homeopathic indications or as directed by your physician.

Warnings:

Consult your health care provider if symptoms persist more than 5 days or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

DO NOT USE

TAMPER EVIDENT: Do not use if safety seal is broken before first use.

Directions for Use:

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3
 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Other Ingredients:

Sucrose

QUESTIONS

Developed and Made by

True Botanica, LLC

1005 Richards Rd., Suite D

Hartland, WI 53029

800-315-8783

www.truebotanica.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

SILICEA 
silicea globule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53645-1161
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X]  in 23 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53645-1161-2	23 g in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/21/2013

Labeler - True Botanica, LLC (182071519)

Establishment
Name	Address	ID/FEI	Business Operations
True Botanica, LLC		182071519	manufacture(53645-1161)