SANA GUT: Package Insert and Label Information

SANA GUT- bacillus clausii suspension
NOVEL PACK LLC

SANA GUT

Bacillus Clausii Spores

Suspension

Helps to balance intestinal bacterial flora due to diverse causes.

Storage Condition

Store at a temperature not exceeding 25 °C in dry place

Dosage

As directed by the physician.

INSTRUCTION BEFORE TAKING THE MEDICINE

Shake before use. To open the Mini Bottle, unscrew and remove the top of the cap. If corpuscles or tiny particles are seen in the Mini Bottle of SANA GUT, it does not mean tha the product is deteriorated. These particles are simply clumps of B.clausii spores. Shake well to obtain a cream white suspension.

INSTRUCTION ON HOW TO TAKE THE MEDICINE

Take the contents as it is or dilued in tea, milk, fruit juices etc. Once open, the drug should be consumed within short time to avoid contamination of the suspension. During treatment with antibiotics, it should be taken uring the interval between antibiotic administraiton.

Container Label
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Container Label
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Box
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Leaflet
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SANA GUT
bacillus clausii suspension
Product Information
Product Type Item Code (Source) NDC:82489-109
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACILLUS CLAUSII (BACILLUS CLAUSII) BACILLUS CLAUSII 2000000000
Inactive Ingredients
Ingredient Name Strength
Water
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82489-109-01 10 SUSPENSION in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 05/02/2022
Labeler — NOVEL PACK LLC (011480879)
Establishment
Name Address ID/FEI Operations
NOVEL PACK LLC 011480879 label

Revised: 05/2022 NOVEL PACK LLC

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