Otc - Active Ingredient
ACTIVE INGREDIENTS: Belladonna 6X, Phosphorus 6X, Pulsatilla 6X, Calcarea carbonica 12X, Silicea 12X.
Type 11 Dizziness Regular
FDA Label NDC 57520-0431
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Type 11 Dizziness Regular (NDC 57520-0431). 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 - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For relief of ringing in the ear from Dizziness, Loss of Balance.
Warnings
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Dosage & Administration
DIRECTIONS: Take two tablets twice a day under the tongue.
Inactive Ingredient
INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Microcrystalline cellulose.
Otc - Questions
Manufactured for:
T-Gone Remedies.
375 N. Stephanie St., Ste 1411
Henderson, NV 89014-8909
Web: www.t-gone.com
Tel: 800-314-2910
Package Label.Principal Display Panel
T-Gone Remedies.
Type 11 Dizziness Regular
HOMEOPATHIC
120 TABLETS
Type 11 Dizziness Regular (Mm1)
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