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 
Method Pharmaceuticals, LLC

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Dothelle DHA

STATEMENT OF IDENTITY:

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

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.

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.

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.

HEALTH CLAIMS:

Prescription Vitamin B9 Containing Dietary Supplement


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

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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:58657-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION53.5 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON38 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN1.8 mg
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12.5 ug
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM5 mg
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS200 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT156 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT39 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58657-121-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT08/20/2015
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
imprint
scoring1
shape
size (solid drugs)15 mm
Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 8/2015
Document Id: 6b066c78-72a9-4975-ba86-d37f2a6dd6c6
Set id: f3a46fb0-5f62-49b6-b228-9bde6206a669
Version: 1
Effective Time: 20150820
 
Method Pharmaceuticals, LLC