Label: DOTHELLE DHA- ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, unspecified form, zinc sulfate, unspecified form, omega-3 fatty acids, doconexent and icosapent capsule, liquid filled

  • NDC Code(s): 58657-121-30
  • Packager: Method Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated August 20, 2015

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

  • STATEMENT OF IDENTITY:

    Dothelle DHA is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

    Close
  • 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.

    Close
  • DOSAGE AND ADMINISTRATION:

    Adults (persons over 12 years of age), One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

    Supplement Facts

    Servings per Bottle: 30

    Serving Size: 1 Capsule %DV for Pregnant

    Each Capsule contains and Lactating Women

    Ferrous Fumarate (anhydrous) 53.5 mg

    (Equiv. to about 17.5 mg of Elemental Iron)

    Polysaccharide Iron Complex 38 mg 194%¶

    (Equiv. to about 17.5 mg of Elemental Iron)

    Vitamin C* 25 mg 42%

    Folic Acid 1 mg 125%

    Vitamin B1 (thiamine mononitrate) 2 mg 118%

    Vitamin B2 (riboflavin) 3 mg 150%

    Vitamin B3* 1.8 mg 9%

    Vitamin B5 (d-calcium pantothenate) 5 mg 50%

    Vitamin B6 (pyridoxine HCl) 25 mg 1000%

    Vitamin B7 (biotin) 300 mcg 100%

    Vitamin B12 (cyanocobalamin) 12.5 mcg 156%

    Copper (as copper sulfate) 2 mg 100%

    Magnesium (as magnesium sulfate) 5 mg 1%

    Zinc (as zinc sulfate) 10 mg 67%

    Omega-3 Fatty acids† 200 mg ‡

    DHA (docosahexaenoic acid) 156 mg ‡

    EPA (eicosapentaenoic acid) 39 mg ‡

    * Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, calcium ascorbate, magnesium ascorbate, potassium ascorbate and sodium ascorbate (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin; and (4) Glutathione.

    ¶ Total Iron: Ferrous Fumarate + Polysaccharide Iron Complex.

    † At least 200 mg Omega-3 Fatty Acids derived from 310 mg fish oil. ‡ Daily value not established.

    ALSO CONTAINS: Gelatin, Glycerin, Soy Lecithin, Yellow Beeswax, Natural Creamy Orange Flavour, L-Lysine Acetate, Hesperidin Complex,  D&C Blue # 1, Sodium Citrate, Titanium Dioxide, Ethyl Vanillin, L-Glutathione, FD&C Yellow # 6.

    HOW SUPPLIED: The Dothelle DHA capsule is an oval, blue soft gelatin capsule, and is imprinted with "M121". Dothelle DHA is dispensed in child-resistant bottles of 30 capsules.

    Close
  • PRECAUTIONS/WARNING: 

    WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (International Normalized Ratio). Omega-3 fatty acids from fish oils (e.g., DHA) should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

    WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

    PRECAUTIONS

    General: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

    Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients.

    Geriatric Use: No clinical studies have been performed in patients 65 and older to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and/or concomitant diseases.

    STORAGE: Store at 20°-25° C (68°-77° F). Excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

    Close
  • HEALTH CLAIMS:

    Prescription Vitamin B9 Containing Dietary Supplement

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 58657-121-30
    Dothelle DHA
    Softgels
    Rx

    30 Capsules

    PRINCIPAL DISPLAY PANEL
NDC 58657-121-30
Dothelle DHA
Softgels
Rx
30 Capsules

    Close
  • INGREDIENTS AND APPEARANCE
    DOTHELLE DHA 
    ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, unspecified form, zinc sulfate, unspecified form, omega-3 fatty acids, doconexent and icosapent capsule, liquid filled
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:58657-121
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 53.5 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 38 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 1.8 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12.5 ug
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM 5 mg
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 mg
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 200 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 156 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 39 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LYSINE ACETATE (UNII: TTL6G7LIWZ)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:58657-121-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 08/20/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    flavor
    imprint
    scoring 1
    shape
    size (solid drugs) 15 mm
    Labeler - Method Pharmaceuticals, LLC (060216698)
    Close