SELECT-OB PLUS DHA PRENATAL SUPPLEMENT PLUS DHA- .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, zinc oxide, and doconexant 
Exeltis USA, Inc.

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.

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SELECT-OB®+DHA

0642-0075-30

Prenatal Supplement with DHA

Rx

COMPOSITION

*
(providing 250mg DHA (docosahexaenoic acid)
Each SELECT-OB® caplet contains:
Vitamin A (as acetate & beta carotene)1700 IU
Vitamin C (as ascorbic acid)60 mg
Vitamin D3 (as cholecalciferol)400 IU
Vitamin E (as dl-alpha tocopheryl acetate)30 IU
Thiamine mononitrate (Vitamin B1)1.6 mg
Riboflavin (Vitamin B2)1.8 mg
Niacin (as niacinamide)15 mg
Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
Folic acid1 mg
Vitamin B12 (as cyanocobalamin)5 mcg
Iron (as polysaccharide iron complex)29 mg
Magnesium (as magnesium oxide)25 mg
Zinc (as zinc oxide)15 mg
Each DHA softgel capsule contains:
Algal oil blend (derived from Natural Algal Oil)
486 mg*

Other Ingredients in Select-OB® caplet: Fructose, Stearic Acid, Mono and Diglycerides, Croscarmellose Sodium, Mixed Berry Flavor WONF, Gelatin (Porcine), Silicon Dioxide, Citric Acid, Magnesium Stearate, Modified Food Starch, Hydroxypropylmethyl Cellulose, Malic Acid, Sucrose, Corn Starch, Dicalcium Phosphate, Sodium Ascorbate, Medium Chain Triglycerides, Sorbic Acid, Tocopherol Concentrate, Sodium Benzoate, dl-Alpha-Tocopherol, Butylated Hydroxytoluene (BHT), Tricalcium Phosphate. Coating: Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polydextrose, Hydroxypropyl Cellulose, Triacetin, Polyethylene Glycol, FD&C Blue #1 / Aluminum Lake, FD&C Blue #2 / Aluminum Lake. Contains: Soy

Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.

INDICATIONS AND USAGE

SELECT OB®+DHA is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. SELECT-OB®+DHA does not contain fish, fish oils, fish proteins or fish byproducts.

CONTRAINDICATIONS

SELECT-OB®+DHA is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitaminB12).

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 a Poison Control Center immediately.

WARNINGS/PRECAUTIONS

SELECT OB®+DHA should be used with caution in patients with known sensitivity or allergy to soy.

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased rick of heart disease can occur. Prolonged use of iron slats may produce iron storage disease.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.

Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.

Avoid overdosage. Keep out of the reach of children.

Drug Interactions

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients

Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

Pediatric Use

Not for pediatric use.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in SELECT OB®+DHA.

DOSAGE AND ADMINISTRATION

Before, during and after pregnancy, chew or swallow one blue Select OB® caplet and swallow one DHA softgel capsule daily, or as directed by a physician.

HOW SUPPLIED

SELECT OB®+DHA is available as a light blue caplet debossed EV0077 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 SELECT-OB® caplets and 5 DHA softgel capsules each), (0642-0075-30) and as professional samples (0642-0075-03).

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

Rx

Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932

1-877-324-9349
www.exeltisusa.com
©2018 Exeltis USA, Inc.

U.S. Patent No. 7,560,123; 8,101,587; 8,197,855; and 8,609,629
Select -OB® is a trademark of Exeltis USA, Inc.

Rev. November 2018

0753001-01

PRINCIPAL DISPLAY PANEL - Kit Carton

0642-0075-30

Select-OB®+DHA
Prenatal Supplement with DHA

Berry flavored BLUE Select-OB® Caplet
can be chewed or swallowed

DHA Softgel Capsule
from natural source DHA

New
Smaller DHA Softgel

DOES NOT CONTAIN
FISH OIL

RX
Unit Dose Pack
30 Caplets and 30 Softgel Capsules
U.S. Patented

PRINCIPAL DISPLAY PANEL - Kit Carton
SELECT-OB PLUS DHA  PRENATAL SUPPLEMENT PLUS DHA
.beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, zinc oxide, and doconexant kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0075
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0642-0075-301 in 1 CARTON04/08/2009
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOX 30 
Part 21 BOX 30 
Part 1 of 2
SELECT-OB 
.beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, and zinc oxide tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE600 [iU]
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A1100 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
NIACINAMIDE (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) NIACINAMIDE15 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.4 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM0.6 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin5 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
Inactive Ingredients
Ingredient NameStrength
FRUCTOSE (UNII: 6YSS42VSEV)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALIC ACID (UNII: 817L1N4CKP)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
TRIACETIN (UNII: XHX3C3X673)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
SODIUM ASCORBATE (UNII: S033EH8359)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Sorbic Acid (UNII: X045WJ989B)  
Tocopherol (UNII: R0ZB2556P8)  
Sodium Benzoate (UNII: OJ245FE5EU)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Tricalcium Phosphate (UNII: K4C08XP666)  
Polydextrose (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize19mm
FlavorBERRY (Mixed Berry) Imprint Code EV0077
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 in 1 BOX; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/08/2009
Part 2 of 2
DHA 
doconexant capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (Amber) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 in 1 BOX; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT04/08/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/08/2009
Labeler - Exeltis USA, Inc. (071170534)

Revised: 10/2019
Document Id: 522770a1-562a-491a-87a0-24563704bcec
Set id: cb5c567a-8733-4004-832e-de8132b8da9e
Version: 4
Effective Time: 20191017
 
Exeltis USA, Inc.