Zyvestra
FDA Label NDC 57520-0398

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 Zyvestra (NDC 57520-0398). 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 - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENTS:  Cocculus indicus 21X, 34X, 55X, Ferrum metallicum 21X, 34X, 55X, Gelsemium sempervirens 21X, 34X, 55X, Phytolacca decandra 32X, 34X, 55X, Pulsatilla 21X, 34X, 55X, Silicea 21X, 34X, 55X.


Otc - Purpose

USES:  For the temporary relief of dizziness and nausea associated with vertigo and motion sickness.


Warnings

WARNINGS:  Consult a physician before use:

If pregnant or breastfeeding

if taking other medications

in children.

Stop use and ask a doctor if:

symptoms worse, persist for more that 48 hours, or reoccur

fever develops.

Do not use if neckband is missing or broken.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration

DIRECTIONS:  Adults:  Take one tablet daily.


Inactive Ingredient

INACTIVE INGREDIENTS:  Lactose, Magnesium stearate, Microcrystalline cellulose.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.


Indications & Usage

USES:  For the temporary relief of dizziness and nausea associated with vertigo and motion sickness.

Otc - Questions

Questions, Comments?

Call 1-800-741-9127

Mfd in the USA for:   PREVAL HEALTH

51 US Route One, Scarborough, ME 04074


Package Label.Principal Display Panel

NDC# 57520-0398-1

ZYVESTRA

RELIEF from symptoms associated with

VERTIGO

DIZZINESS

NAUSEA

Homeopathic Medicine

60 Tablets

Zyvestra (Mm1)

Zyvestra (Mm1)

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