SUREBIOTIC- lactobacillus acidophilus and bifidobacterium animalis lactis capsule

SureBiotic by

Drug Labeling and Warnings

SureBiotic by is a Other medication manufactured, distributed, or labeled by Redmont Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

SureBiotic 71741-395-30
Dietary Supplement
Dispensed by Prescription
DESCRIPTION

SureBiotic is an orally administered prescription probiotic dietary supplement.

STATEMENT OF IDENTITY

Supplement Facts
Serving size 1 Capsule
Amount per Serving:		% Daily Value
* Daily value not established
Lactobacillus Acidophilus	16 Billion	*
Bifidobacterium Animalis Lactis	15 Billion	*

OTHER INGREDIENTS: Modified Cellulose, Silicon Dioxide, Magnesium Stearate.

Preservative Free and Gluten Free

INDICATIONS

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

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

SureBiotic 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 other medications.
ADVERSE REACTIONS

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Redmont Pharmaceuticals, LLC at 1-800-986-5909.
DOSAGE AND ADMINISTRATION

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

Bottle of 30 capsules (71741- 395-301). Capsule is off-white, oblong.

1 Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

STORAGE AND HANDLING

Store 15°- 30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light, moisture and exceeding 85% humidity. Keep in a cool, dry place.

TAMPER EVIDENT

Do not use if seal is broken or missing.

HEALTH CLAIM

MADE IN USA

Distributed by:

Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any diseases.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

71741-395-30

SureBiotic

PROBIOTIC SUPPORT

Lactobacillus Acidophilus
Bifidobacterium Animalis Lactis
31 Billion CFU's
DIETARY SUPPLEMENT

30 CAPSULES

Dispensed by Prescription

Principal Display Panel - 30 Capsule Bottle Label

INGREDIENTS AND APPEARANCE

SUREBIOTIC
lactobacillus acidophilus and bifidobacterium animalis lactis capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71741-395
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lactobacillus Acidophilus (UNII: 1PRR1V42V5) (Lactobacillus Acidophilus - UNII:1PRR1V42V5)	Lactobacillus Acidophilus	16000000000 [CFU]
Bifidobacterium Animalis Lactis (UNII: 5307V7XW8I) (Bifidobacterium Animalis Lactis - UNII:5307V7XW8I)	Bifidobacterium Animalis Lactis	15000000000 [CFU]

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:71741-395-30	30 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Dietary Supplement		07/10/2024

	Amount Per Serving	% Daily Value
Supplement Facts
Serving Size :		Serving per Container :
color
scoring	1
shape
size (solid drugs)	23 mm

Labeler - Redmont Pharmaceuticals, LLC (080843607)