ACIDOPHILUS LACTOBACILLUS
Acidophilus Lactobacillus Oral Capsule
b17b6e92-93ac-4184-86ef-2f79e50d3aac
DIETARY SUPPLEMENT
Sep 5, 2025
Krewe Pharma, LLC
DUNS: 139887329
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACIDOPHILUS LACTOBACILLUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGING:
HEALTH CLAIM SECTION
HEALTH CLAIM:
Acidophilus Lactobacillus Oral Capsule
STATEMENT OF IDENTITY SECTION
DESCRIPTION:
Acidophilus Lactobacillus Oral Capsules are clear capsules dispensed in plastic bottles of 30 ct.
87021-0100-30
Reserved for Professional Recommendation
This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
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:
Krewe Pharma
New Port Richey, FL 34652
WARNINGS SECTION
WARNINGS AND PRECAUTIONS:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
As with any supplement, if you are pregnant, nursing, taking medication, or have a medical condition, ask a health professional before taking this product.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
PRECAUTIONS SECTION
PRECAUTIONS:
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any
of the ingredients.
PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to
any of the ingredients.
ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of
folic acid. Consult your physician immediately if adverse side effects occur.
KEEP OUT OF THE REACH OF CHILDREN.
SAFE HANDLING WARNING SECTION
STORAGE:
Store at 20° - 25° C (68° - 77° F); excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Tempature].
Store in the Refrigerator after opening. DO NOT FREEZE.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION:
Usual adult dose is 2 capsules by mouth daily once daily, or as prescribed by a licensed medical practitioner.