Probiotika-30: Package Insert and Label Information

PROBIOTIKA-30- lactobacillus acidophilus and bifidobacterium lactis bi-07 capsule
Singular Lifesciences, LLC

STATEMENT OF IDENTITY


Probiotika-30 is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.


Probiotika-30 should be administered under the supervision of a licensed medical practitioner.

WARNING AND PRECAUTIONS


Probiotika-30 capsules should only be used under the direction and supervision of a licensed medical practitioner. This product is contraindicated in patients with known hypersensitivity to any of the ingredients. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

STORAGE AND HANDLING:


Store at 20°-25°C (66°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room
Temperature.]
Protect from heat, light and moisture.
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident: Do not use if seal is broken or missing.

HEALTH CLAIM:


PROBIOTIKA-30
Capsule
Dietary Supplement

Product Label Probiotika-30

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PROBIOTIKA-30
lactobacillus acidophilus, bifidobacterium lactis bi-07 capsule
Product Information
Product Type Item Code (Source) NDC:83035-5848
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 80 mg
BIFIDOBACTERIUM LACTIS BI-07 (BIFIDOBACTERIUM LACTIS BI-07) BIFIDOBACTERIUM LACTIS BI-07 75 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POLYGLYCERYL-3 RICINOLEATE
SILICON DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 30mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:83035-5848-3 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 11/14/2022
Labeler — Singular Lifesciences, LLC (118806628)
Registrant — Singular Lifesciences, LLC (118806628)

Revised: 11/2022 Singular Lifesciences, LLC

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