Label: PROMELLA- lactobacillus acidophilus, bifidobacterium animalis lactis capsule
- NHRIC Code(s): 72287-521-56
- Packager: Amella Pharma, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated May 1, 2020
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HEALTH CLAIM:
Promella in Prebiotic Capsules Dietary Supplement
Dispensed by PrescriptionSupplement 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.
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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.
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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.
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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.
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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 0881604/2020 AP7002v1
- STORAGE:
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INGREDIENTS AND APPEARANCE
PROMELLA
lactobacillus acidophilus, bifidobacterium animalis lactis capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:72287-521 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 16000000000 [CFU] Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) INULIN (UNII: JOS53KRJ01) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:72287-521-56 56 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 04/21/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 20 mm scoring 1 Labeler - Amella Pharma, LLC (081189492)
