Label: BUMP DHA- folate, vitamin b2, vitamin b6, vitamin b12, potassium iodide, zinc biglycinate, magnesium oxide, nadh, dha, carbonyl iron capsule

  • NDC Code(s): 23359-110-05, 23359-110-30, 23359-110-90
  • Packager: Centurion Labs, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 12, 2017

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

  • DESCRIPTION

    BumP DHA is a food for special dietary use in women who are pregnant or lactating.

    Supplement Facts
    Serving Size: 1 Softgel Capsule
    Amount per Serving:

    %Daily Value

    (Pregnant Women)

     Calories  7.1
     Calories from fat  4.6
     Total Fat  0.5 grams  *
     Folate [as 1mg of L-methylfolate magnesium and 1mg of folinic acid]  2 mg 250%

     Vitamin B2

    [as 1mg Flavin adenine dinucleotide (FAD), 2mg Flavin Mononucleotide (FMN)]

     3 mg 214%
     Vitamin B6 [as 20mg Pyridoxine HCL, 5mg pyridoxal 5’ phosphate]  25mg 1000%

     Vitamin B12

    [as 500mcg of Adenosylcobalamin and 500mcg methylcobalamine]

     1 mg 12500%
     Iodine (Potassium Iodide)  250mcg 168%
     Zinc Biglycinate  15mg 136%
     Magnesium Oxide  125mg 44%
     Nicotinamide adenine dinucleotide hydride (NADH)  25 mcg 0.14%
     Omega-3 Fatty Acid- (DHA)  300mg *
     Carbonyl Iron  15mg  84%

    *Daily Value not established

    Other ingredients: Sunflower Lecithin (non-GMO), Yellow Beeswax, Olive Oil, Bovine Gelatin, Glycerin, Annatto Powder, Titanium Dioxide, Natural Creamy Orange Flavor, Purified Water.

    Bump DHA™ is a food for special dietary use dispensed by prescription, for women who are preparing for pregnancy, are pregnant or for postnatal mothers.  Bump DHA™ contains a proprietary blend of biologically active folate, vitamins, minerals and long-chain polyunsaturated fatty acids, derived from food sources.

    This product is not an Orange Book product.

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  • WARNINGS

    WARNING:  Ingestion of more than 3 grams of omega-3 fatty acids (such as ALA, EPA, and DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

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  • RECOMMENDED USE

    Bump DHA™ soft gels are food for special dietary use administered under the supervision of a medical practitioner, for women who are preparing for pregnancy, pregnant or are postnatal.

    The usual adult dose is one soft gel daily or as directed by a medical professional.

    If you are pregnant inform your doctor, or if nursing, your child’s doctor that you are using this product.

    Bump DHA™ is contraindicated in patients with known hypersensitivity to any of the ingredients.

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  • HOW SUPPLIED

    BumP DHA™ is supplied as oval, annatto-colored soft gelatin capsules with "B-DHA" on one side. In bottles of 30 softgels 23359-110-30* and bottles of 90 softgels 23359-110-90*

    BumP DHA™ is also supplied to licensed healthcare practitioners as samples in bottles of 5 softgels, 23359-110-05* Professional samples- not for sale.

    Centurion Labs, 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 requirements of pharmacy and health insurance computer systems.

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  • STORAGE

    Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light, moisture, and excessive heat.

    Administer under the supervision of a medical practitioner.

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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  • HEALTH CLAIM

    GLUTEN FREE
    SUGAR FREE
    DYE FREE

    Manufactured for:
    CENTURION LABS, LLC
    Birmingham, AL 35242
    1-888-886-2061

    MADE IN CANADA

    PATENTS: US Patent Nos. 7582418, 7838042 and other patent applications pending.

    TRADEMARKS: Bump DHA™ is a trademark of Centurion Labs, LLC (Birmingham,
    Alabama, USA). L-methylfolate magnesium is under license from Viva Pharmaceutical Inc. (Canada).

    Rev. 3/17

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  • INGREDIENTS AND APPEARANCE
    BUMP DHA 
    folate, vitamin b2, vitamin b6, vitamin b12, potassium iodide, zinc biglycinate, magnesium oxide, nadh, dha, carbonyl iron capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:23359-110
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE MAGNESIUM 1 mg
    LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN 1 mg
    FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE 1 mg
    FLAVIN MONONUCLEOTIDE (UNII: 7N464URE7E) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE 2 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 5 mg
    COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE 500 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 250 ug
    ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC GLYCINATE 15 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 125 mg
    NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH 25 ug
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 300 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:23359-110-30 30 in 1 BOTTLE
    2 NHRIC:23359-110-90 90 in 1 BOTTLE
    3 NHRIC:23359-110-05 5 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 03/24/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    shape
    size (solid drugs) 14 mm
    scoring 1
    imprint
    flavor
    Labeler - Centurion Labs, LLC (016481957)
    Establishment
    Name Address ID/FEI Business Operations
    Viva Pharmaceuticals 253288898 manufacture(23359-110)
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