Label: VITA-PAC- ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous bisglycinate capsule

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated January 30, 2023

If you are a consumer or patient please visit this version.

  • HEALTH CLAIM:

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

    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 mg147%
     Folate (as 5-Methyltetrahydrofolate as Mangafolate-C) 900 mcg375%
     Vitamin B12 (as Methylcobalamin)    100 mcg4,166%

    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

    image description

  • INGREDIENTS AND APPEARANCE
    VITA-PAC 
    ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous bisglycinate capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:82379-1200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
    cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol0.0125 mg
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE1.4 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS2.5 mg
    FOLATE SODIUM (UNII: 9P9W8GGU78) (FOLIC ACID - UNII:935E97BOY8) FOLATE SODIUM0.9 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN0.1 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    IRON (UNII: E1UOL152H7) (FERROUS BISGLYCINATE - UNII:SFW1D987QV) FERROUS BISGLYCINATE13 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:82379-1200-130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement10/18/2022
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    imprint
    size (solid drugs)25 mm
    scoring1
    Labeler - Trell Pharma (118380801)