Label: BUMP DHA- folate, vitamin b2, vitamin b6, vitamin b12, potassium iodide, zinc biglycinate, magnesium oxide, nadh, dha, carbonyl iron capsule
- NHRIC Code(s): 23359-110-30, 23359-110-90, 23359-110-05
- 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.
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DESCRIPTION
BumP DHA is a food for special dietary use in women who are pregnant or lactating.
Supplement Facts
Serving Size: 1 Softgel CapsuleAmount 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.
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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.
- STORAGE
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HEALTH CLAIM
GLUTEN FREE
SUGAR FREE
DYE FREEManufactured for:
CENTURION LABS, LLC
Birmingham, AL 35242
1-888-886-2061MADE 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
- PRINCIPAL DISPLAY PANEL
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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 capsuleProduct 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)