Vita-Pac: Package Insert and Label Information

VITA-PAC- ascorbic acid, cholecalciferol, thiamine hydrochloride, pyridoxal phosphate anhydrous, folate sodium, methylcobalamin, calcium carbonate and iron capsule
Trell Pharma

HEALTH CLAIM:

Vita-Pac Capsule — Prenatal/Postnatal/Folate Health Dietary Supplement

Dispensed by Prescription

Supplement Facts
Serving Size: 1 Capsule

Servings per Bottle: 30

Amount Per Serving: % Daily Value
Vitamin C (as Ascorbic Acid) 125 mg 104%
Calcium (as Calcium Carbonate from Aquamin Red Algae) 200 mg 15%
Iron (as Ferrous Bisglycinate from Ferrochel Chelate) 13 mg 72%
Vitamin D3 (as Cholecaliciferol from Veg D3) 12.5 mcg 63%
Thiamine (as Thiamine HCL) 1.4 mg 117%
Vitamin B6 (as Pyridoxal-5-Phosphate) 2.5 mg 147%
Folate (as 5-Methyltetrahydrofolate as Mangafolate-C) 900 mcg 375%
Vitamin B12 (as Methylcobalamin) 100 mcg 4,166%

OTHER INGREDIENTS: Vegetable Cellulose (Capsule), Silica Dioxide

WARNING AND PRECAUTIONS

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

Vita-Pac should only be used under the direction and supervision of a licensed medical practitioner.

WARNING: Children under 18, pregnant or nursing women, and individuals with known medical conditions should consult a physician before using this or any dietary supplement.

In case of accidental overdoes, call a doctor or poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).

DOSAGE & ADMINISTRATION

Take one (1) capsule once daily preferably with meals or as directed by medical practitioner.

If you are pregnant or nursing, ask a healthcare professional.

Vita-Pac should be administered under the supervision of a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

Vita-Pac

Dietary Supplement

NHRIC: 82379-1200-01 *

Bottles contain 30 Capsules

Distributed in the USA by:
Trell Pharma, LLC

*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.

† The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product 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 statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

*Trell Pharma 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.

†† 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. 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)

PACKAGE LABEL

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VITA-PAC
ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous bisglycinate capsule
Product Information
Product Type Item Code (Source) NDC:82379-1200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 125 mg
cholecalciferol (CHOLECALCIFEROL) cholecalciferol 0.0125 mg
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.4 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (PYRIDOXAL PHOSPHATE ANHYDROUS) PYRIDOXAL PHOSPHATE ANHYDROUS 2.5 mg
FOLATE SODIUM (FOLIC ACID) FOLATE SODIUM 0.9 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 0.1 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
IRON (FERROUS BISGLYCINATE) FERROUS BISGLYCINATE 13 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82379-1200-1 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 10/18/2022
Labeler — Trell Pharma (118380801)

Revised: 11/2022 Trell Pharma

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