Probiotika-30 by Singular Lifesciences, LLC

Probiotika-30 by

Drug Labeling and Warnings

Probiotika-30 by is a Other medication manufactured, distributed, or labeled by Singular Lifesciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROBIOTIKA-30- lactobacillus acidophilus, bifidobacterium lactis bi-07 capsule 
Singular Dreamer Ltd

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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 
lactobacillus acidophilus, bifidobacterium lactis bi-07 capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:83035-5848
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	80 mg
BIFIDOBACTERIUM LACTIS BI-07 (UNII: W5MJX9C73Y) (BIFIDOBACTERIUM LACTIS BI-07 - UNII:W5MJX9C73Y)	BIFIDOBACTERIUM LACTIS BI-07	75 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:83035-5848-3	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		11/14/2022	02/10/2023

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
scoring	1
shape
size (solid drugs)	30 mm
color

Labeler - Singular Dreamer Ltd (129504103)

Registrant - Singular Dreamer Ltd (129504103)

Revised: 2/2023

Document Id: e7c248ad-f947-4ad2-b1b3-00823782962d

58476-3

Set id: 9cdcc529-c84b-4356-9380-414b12ada685

Version: 2

Effective Time: 20230221