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SPL v1

SPL

SPL Set ID 474780d5-dd88-8f1a-e063-6294a90a03dc

Route

ORAL

Published

Effective Date 2025-10-15

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Thiamine Ion (5 mg) Niacinamide (35.7 mg) Pyridoxine (25 mg) Ascorbic Acid (65 mg) Pantothenic Acid (20 mg) Riboflavin (1 mg) Folic Acid (0.5 mg) Methylcobalamin

Inactive Ingredients

Cellulose, Microcrystalline Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Shape: oval Color: brown Size: 19 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2025-12-29

Description

Lunavira is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.

Medication Information

Warnings and Precautions

WARNING If you are pregnant or nursing, ask a health care professional before using this product. Keep this product out of the reach of children.

Dosage and Administration

Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner.

Dosage Forms and Strengths

Lunavira capsules are supplied as clear capsules dispensed in HDPE plastic bottles of 30 count (85477-623-30).

Description

Lunavira is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.

Section 34084-4

Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Section 44425-7

STORAGE: Store at controlled room temperature 15°-30° C (59°-86° F). Keep in a cool dry place.

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

Dosage and Administration (34068-7)

Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner.

Dosage Forms and Strengths (34069-5)

Lunavira capsules are supplied as clear capsules dispensed in HDPE plastic bottles of 30 count (85477-623-30).

Warnings and Precautions (34071-1)

WARNING If you are pregnant or nursing, ask a health care professional before using this product. Keep this product out of the reach of children.

Section 34084-4 (34084-4)

Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Description (34089-3)

Lunavira is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.

Section 44425-7 (44425-7)

STORAGE: Store at controlled room temperature 15°-30° C (59°-86° F). Keep in a cool dry place.

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

[{"name": "THIAMINE ION", "unii": "4ABT0J945J", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "35.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PYRIDOXINE", "unii": "KV2JZ1BI6Z", "classCode": "ACTIM", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PANTOTHENIC ACID", "unii": "19F5HK2737", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "RIBOFLAVIN", "unii": "TLM2976OFR", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FOLIC ACID", "unii": "935E97BOY8", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "METHYLCOBALAMIN", "unii": "BR1SN1JS2W", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34068-7": "Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner.", "34069-5": "Lunavira capsules are supplied as clear capsules dispensed in HDPE plastic bottles of 30 count (85477-623-30).", "34071-1": "WARNING If you are pregnant or nursing, ask a health care professional before using this product. Keep this product out of the reach of children.", "34084-4": "Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.", "34089-3": "Lunavira is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.", "44425-7": "STORAGE: Store at controlled room temperature 15°-30° C (59°-86° F). Keep in a cool dry place. MADE IN USA Distributed by: 888-321-2821 Oncora Pharma Dallas, TX 75161", "60561-8": "KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:55.493384 · Updated: 2026-03-14T22:42:19.657154