GLP DLax
GLP-DLax Tablets
28316b4d-3a83-4b66-9483-dc5613733111
DIETARY SUPPLEMENT
Jun 16, 2025
Basiem, LLC
DUNS: 079686680
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Inulin, Slippery Elm, Cape Aloe, Cascara sagrada, Cholecalciferol, Folic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
GLP-DLAX LABEL:
Label:
PRECAUTIONS SECTION
SAFE HANDLING
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to
any of the ingredients. GLP-DLax is contraindicated in patients with
hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic
effects of vitamin D, and hypervitaminosis D.
WARNINGS AND PRECAUTIONS
Tell your doctor if you have kidney problems or thyroid disease. Do not use
this product if you have abdominal pain, diarrhea, or loose stools. Rectal
bleeding and/or failure to have a bowel movement after the use of a laxative
formula may be an indication of a more serious condition. Should this occur,
or if you have a known medical condition and are taking this medication,
consult your healthcare provider about the risks and benefits prior to taking
this or any dietary supplement.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral
administration of folic acid.
You should call your doctor for medical advice about serious adverse events.
To report adverse side effects or to obtain product information, contact
Basiem, LLC, at 1-844-551-9911.
KEEP OUT OF REACH OF CHILDREN
HEALTH CLAIM SECTION
HOW SUPPLIED HEALTH CLAIM
GLP-DLax, Metabolic Support
Dietary Supplement
Vegan tablets are light brown and have an oval shape
Bottles contain 30 Tablets 69597-362-30*
Manufactured in USA for:
Basiem, LLC
Madisonville, LA 70447
Rev. 05/2025
*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.
Dispensed by Prescription**†**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.
This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). 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.
1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)
DOSAGE & ADMINISTRATION SECTION
DOSAGE
Take two tablets once or twice daily with 8-12 oz of water or as directed by a healthcare practitioner.
STATEMENT OF IDENTITY SECTION
STATEMENT OF IDENTITY
GLP-DLax Tablets 69597-362-30*
Dietary Supplemement
Dispensed by Prescription†
|
** Amount Per Serving (2 tablets):** |
** %DV** | |
|
Vitamin D (as cholecalciferol) |
250 mcg (10,000 IU) |
1250% |
|
Folate (from 2,000 mcg Folic Acid) |
3,334 mcg DFE |
834% |
|
Inulin (from organic agave (heart) extract) 1,000 mg * Slippery Elm (bark) 850 mg * Aloe Vera (leaf) 450 mg * Cascara sagrada (bark) 270 mg * | ||
|
*Daily Values (DV) not established |
OTHER INGREDIENTS: Cellulose, calcium stearate, calcium phosphate, silica
GLP-DLax capsules are an orally administered prescription vitamin formulation
for the clinical dietary management of suboptimal nutritional status in
patients where advanced supplementation is required and for patients with
occasional constipation to restore and maintain regularity.
These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent disease.
GLP-DLax 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.