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

Select-OB Plus DHA by

Drug Labeling and Warnings

Select-OB Plus DHA by is a Prescription medication manufactured, distributed, or labeled by Exeltis USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 acid	1 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).

BOXED WARNING

(What is this?)

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0642-0075

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0642-0075-30	1 in 1 CARTON	04/08/2009

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOX	30
Part 2	1 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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	600 [iU]
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	1100 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [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)	Thiamine	1.6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.8 mg
NIACINAMIDE (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	NIACINAMIDE	15 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	0.4 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	0.6 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA)	Cobalamin	5 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	29 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838)	MAGNESIUM OXIDE	25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	ZINC OXIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor	BERRY (Mixed Berry)	Imprint Code	EV0077
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BOX; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/08/2009

Part 2 of 2

DHA 
doconexant capsule

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	250 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (Amber)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BOX; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		04/08/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/08/2009

Labeler - Exeltis USA, Inc. (071170534)