38e463d1-f608-7cb5-e063-6294a90a4abb
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Aflora is a prescription multivitamin/multimineral dietary supplement.
Medication Information
Warnings and Precautions
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately.
Indications and Usage
Aflora is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
Dosage and Administration
One tablet daily or as directed by a physician.
Dosage Forms and Strengths
Bottles of 30 Tablets (85477-904-30). Tablet is light blue, oblong.
Contraindications
Aflora is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Description
Aflora is a prescription multivitamin/multimineral dietary supplement.
Section 34084-4
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 reports adverse side effects or to obtain product information, contact Oncora Pharma at 888-321-2821.
Section 42229-5
*Oncora Pharma does not represent this products code to be National Drug Code
(NDC). Products codes are formatted according to standard industry practice, to meet the
formatting requirement by pedigree reporting and supply-chain control including
pharmacies.
This products is a prescription-folate with or without other dietary ingredients the - due to
increased folate levels increased risk associated with masking B12 deficiency (pernicious
anemia) requires administration under the care of a licensed medical practitioner(64 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.
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
statues 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 (39 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)
Storage and Handing
Section 42232-9
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Section 44425-7
STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture.
TAMPER EVIDENT: Do not use if seal is broken or missing.
MADE IN USA
Distributed by:
888-321-2821
Oncora Pharma
Dallas, TX 75161
Section 51945-4
Section 60561-8
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Structured Label Content
Indications and Usage (34067-9)
Aflora is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
Dosage and Administration (34068-7)
One tablet daily or as directed by a physician.
Dosage Forms and Strengths (34069-5)
Bottles of 30 Tablets (85477-904-30). Tablet is light blue, oblong.
Contraindications (34070-3)
Aflora is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings and Precautions (34071-1)
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately.
Section 34084-4 (34084-4)
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 reports adverse side effects or to obtain product information, contact Oncora Pharma at 888-321-2821.
Description (34089-3)
Aflora is a prescription multivitamin/multimineral dietary supplement.
Section 42229-5 (42229-5)
*Oncora Pharma does not represent this products code to be National Drug Code
(NDC). Products codes are formatted according to standard industry practice, to meet the
formatting requirement by pedigree reporting and supply-chain control including
pharmacies.
This products is a prescription-folate with or without other dietary ingredients the - due to
increased folate levels increased risk associated with masking B12 deficiency (pernicious
anemia) requires administration under the care of a licensed medical practitioner(64 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.
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
statues 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 (39 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)
Storage and Handing
Section 42232-9 (42232-9)
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Section 44425-7 (44425-7)
STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture.
TAMPER EVIDENT: Do not use if seal is broken or missing.
MADE IN USA
Distributed by:
888-321-2821
Oncora Pharma
Dallas, TX 75161
Section 51945-4 (51945-4)
Section 60561-8 (60561-8)
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:47:58.065559 · Updated: 2026-03-14T22:50:04.032953