ZELAC

Manufacturer
Foxland Pharmaceuticals, Inc. | Formulation Technology Incorporated
Effective date
2023-02-20
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:40

Label at a glance#

ProductZELAC Probiotic Support
Active ingredientLACTOBACILLUS ACIDOPHILUS, BIFIDOBACTERIUM ANIMALIS LACTIS
Label structure7 sections

Dosage and administration

Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

Storage and handling

Store at 20°-25°C (68° -77°F); excursions permitted to 15°-30°C (59°- 86°F) [See USP Controlled Room Temperature]. Protect from heat, light and moisture.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 CapsuleServings per container: 30
Amount Per Serving:%DV
Lactobacillus Acidophilus8 Billion*
Bifidobacterium Lactis7.5 Billion*

OTHER INGREDIENTS: Gelatin, Microcrystalline Cellulose, Maltodextrin, Magnesium Stearate, Silica.

Description 

HEALTH CLAIM SECTION

ZELAC capsules is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required, and maintenance of good health is needed.

Warnings and Precautions

WARNINGS SECTION

ZELAC capsules should only be used under the directions and supervision of a licensed medical practitioner.

Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications.

KEEP OUT OF REACH OF CHILDREN

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

Precautions

PRECAUTIONS SECTION

Tamper Evident:  Do not use if seal is broken or missing.

Dispensed by Prescription

Storage and Handling

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68° -77°F); excursions permitted to 15°-30°C (59°- 86°F) [See USP Controlled Room Temperature].

Protect from heat, light and moisture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2166201Bifidobacterium animalis 7.5 Billion UNT / Lactobacillus acidophilus 8 Billion UNT Oral CapsulePSN2
2166201Bifidobacterium animalis 7500000000 UNT / Lactobacillus acidophilus 8000000000 UNT Oral CapsuleSCD2
2166201Bifidobacterium animalis 7.5 Billion UNT / Lactobacillus acidophilus 8 Billion UNT Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69067-070-30ZELAC Probiotic Support30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69067-070ZELAC PROBIOTIC SUPPORT (LACTOBACILLUS ACIDOPHILUS AND BIFIDOBACTERIUM ANIMALIS LACTIS) CAPSULE [FOXLAND PHARMACEUTICALS, INC.]21 package rows20230222_e2f839ba-14ba-471e-96ba-dc7333f896e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69067-070-30EA - Each69067-070d9faabb9-f685-4cba-a29d-d70248d8353712019-06-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69067-07069067-070-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.