SPL v2
SPL
SPL Set ID 33da017b-1e8c-d41c-e063-6394a90aab8c
Route
ORAL
Published
Effective Date 2025-02-24
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferrous Cation (20 mg) Iodide Ion (0.15 mg) Pyridoxine (26 mg) Beta Carotene (0.3 mg) Ascorbic Acid (60 mg) Cholecalciferol (0.1 mg) Biotin (0.28 mg) Folic Acid (1.67 mg) Cyanocobalamin (0.013 mg) Calcium Cation (80 mg) Magnesium Cation (25 mg) .alpha.-tocopherol, Dl- (4.5 mg)
Inactive Ingredients
Stearic Acid Cellulose, Microcrystalline Silicon Dioxide Magnesium Stearate Maltodextrin Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-02-24

Description

Nutralyn 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

Nutralyn 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 (85477-903-30). Tablet is light blue, oblong.

Contraindications

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

Description

Nutralyn 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)

Nutralyn 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 (85477-903-30). Tablet is light blue, oblong.

Contraindications (34070-3)

Nutralyn 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)

Nutralyn 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

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