Probichew Probiotic Support: Package Insert and Label Information

PROBICHEW PROBIOTIC SUPPORT- bacillus coagulans and inulin bar, chewable
Basiem, LLC

STATEMENT OF IDENTITY

PROBICHEW Dietary Supplemement

Dispensed by Prescription

Amount Per Serving: %DV

Bacillus Coagulans
21 Billion *
Dietary Fiber (as Inulin) 1 gram 4%
*Daily Values (DV) not established
image description
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OTHER INGREDIENTS: Sodium, Potassium, Calcium, Sugar Alcohol, Maltitol Syrup, Inulin, Palm Oil, Gum Arabic, Mono and Diglycerides, Sunflower Lecithin, Sea Salt, Natural Flavor, Stevia Extract, Whey Protein Isolate

PROBICHEW is an orally administered prescription probiotic/prebiotic 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.

PROBICHEW should be administered under the supervision of a licensed medical practitioner.

PROBICHEW is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are Generally Recognized as Safe (GRAS) for their intended use

DOSAGE

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

If you are pregnant or nursing, ask a healthcare professional.

PROBICHEW should be administered under the supervision of a licensed medical practitioner.

DIRECTIONS FOR USE: REMOVE FOIL BEFORE CONSUMING CHEW. Consume entire chew or as directed by a healthcare professional.

SAFE HANDLING

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PROBICHEW chews should only be used under the direction 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 medications.

KEEP OUT OF REACH OF CHILDREN

STORAGE

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

HOW SUPPLIED HEALTH CLAIM

PROBICHEW, Probiotic/Prebiotic Support

Dietary Supplement

Chews are beige in color and individually wrapped in a bronze and silver foil.

Bottles contain 30 Chews 69597-350-30*

Manufactured in USA for:
Basiem, LLC

Madisonville, LA 70447

Rev. 12/2019

*Basiem does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

† The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

PRINCIPAL DISPLAY PANEL — 30 Chew Bottle Label

PRINCIPAL DISPLAY PANEL -- 30 Capsule Bottle Label
(click image for full-size original)

PROBICHEW PROBIOTIC SUPPORT
bacillus coagulans and fiber bar, chewable
Product Information
Product Type Item Code (Source) NDC:69597-352
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACILLUS COAGULANS (BACILLUS COAGULANS) BACILLUS COAGULANS 21000000000 [CFU]
INULIN (INULIN) INULIN 1000 mg
Inactive Ingredients
Ingredient Name Strength
MALTITOL
PALM OIL
ACACIA
LECITHIN, SUNFLOWER
SEA SALT
STEVIA REBAUDIUNA LEAF
WHEY PROTEIN HYDROLYSATE
SODIUM
POTASSIUM
CALCIUM
MANNITOL
Product Characteristics
Color brown (Beige) Score no score
Shape SQUARE Size 28mm
Flavor CARAMEL Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69597-352-30 30 BAR, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 12/06/2019
Labeler — Basiem, LLC (079686680)

Revised: 01/2020 Basiem, LLC

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