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BumP DHA

Generic Name: multi-vitamin, mineral supplement
Dosage Form: softgel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

BumP DHA 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.

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.

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.

How is BumP DHA Supplied

BumP DHA™ is supplied as oval, annatto-colored soft gelatin capsules with "B-DHA" on one side. In bottles of 30 softgels 23359-301-30* and bottles of 90 softgels 23359-301-90*

BumP DHA™ is also supplied to licensed healthcare practitioners as samples in bottles of 5 softgels, 23359-301-05* 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

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.

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

BumP DHA 
folate, vitamin b2, vitamin b6, vitamin b12, potassium iodide, zinc biglycinate, magnesium oxide, nadh, dha, carbonyl iron capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23359-301
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE MAGNESIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE MAGNESIUM 1 mg
LEUCOVORIN (LEUCOVORIN) LEUCOVORIN 1 mg
FLAVIN ADENINE DINUCLEOTIDE (FLAVIN ADENINE DINUCLEOTIDE) FLAVIN ADENINE DINUCLEOTIDE 1 mg
FLAVIN MONONUCLEOTIDE (FLAVIN MONONUCLEOTIDE) FLAVIN MONONUCLEOTIDE 2 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (PYRIDOXAL PHOSPHATE ANHYDROUS) PYRIDOXAL PHOSPHATE ANHYDROUS 5 mg
COBAMAMIDE (COBAMAMIDE) COBAMAMIDE 500 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 250 ug
ZINC GLYCINATE (ZINC CATION) ZINC GLYCINATE 15 
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 125 mg
NADH (NADH) NADH 25 ug
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 300 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 15 mg
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SUNFLOWER  
YELLOW WAX  
OLIVE OIL  
GELATIN  
GLYCERIN  
ANNATTO  
TITANIUM DIOXIDE  
WATER  
Product Characteristics
Color red (annatto-colored) Score no score
Shape capsule Size 14mm
Flavor ORANGE Imprint Code B;DHA
Contains         
Packaging
# Item Code Package Description
1 NDC:23359-301-30 30 CAPSULE in 1 BOTTLE
2 NDC:23359-301-90 90 CAPSULE in 1 BOTTLE
3 NDC:23359-301-05 5 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/24/2017
Labeler - Centurion Labs, LLC (016481957)
Establishment
Name Address ID/FEI Operations
Viva Pharmaceuticals 253288898 manufacture(23359-301)
Revised: 03/2017
 
Centurion Labs, LLC



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