Promella: Package Insert and Label Information

PROMELLA- lactobacillus acidophilus and bifidobacterium animalis lactis capsule
Amella Pharma, LLC

HEALTH CLAIM:

Promella in Prebiotic Capsules Dietary Supplement
Dispensed by Prescription

Supplement Facts
Serving Size: 2 Capsules
Servings Per Container: 28
Amount Per Serving: % Daily Value

Probiotic blend

(Lactobacillus acidophilus,

Bifidobacterium animalis lactis)

64 billion cfu **
** Daily values not established

Other Ingredients: Hypromellose (capsule) and Inulin.

DESCRIPTION

Promella in Prebiotic 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.

Promella in Prebiotic should be administered under the supervision of a licensed medical practitioner.

WARNINGS AND PRECAUTIONS

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

Promella in Prebiotic 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.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 to 2 capsule(s) by mouth daily with or without food.

INDICATIONS AND USAGE

Promella in Prebiotic 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.

HOW SUPPLIED:

Promella in Prebiotic is supplied as clear capsules dispensed in HDPE plastic bottles of 56ct.

72287-521-56

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Amella Pharma, LLC
East Brunswick, NJ 08816

04/2020 AP7002v1

STORAGE:

Product is sensitive to moisture and heat. Keep bottle tightly closed in a dry, cool place, not exceeding room temperature 25°C (77°F). Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS OUT OF THE REACH OF CHILDREN.

Probiotic Support

32 Billion CFU Capsules

Do NOT remove the desiccant from the container.

1-844-385-0850

PACKAGING

image description
(click image for full-size original)
PROMELLA
lactobacillus acidophilus, bifidobacterium animalis lactis capsule
Product Information
Product Type Item Code (Source) NDC:72287-521
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 16000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (BIFIDOBACTERIUM ANIMALIS LACTIS) BIFIDOBACTERIUM ANIMALIS LACTIS 16000000000 [CFU]
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
INULIN
Product Characteristics
Color white Score no score
Shape capsule Size 20mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72287-521-56 56 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 04/21/2020
Labeler — Amella Pharma, LLC (081189492)

Revised: 05/2020 Amella Pharma, LLC

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