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

Prenatal Supplement with DHA

Supplement Facts
Serving Size 1 Caplet and 1 Softgel Capsule
Each Caplet contains % Daily Value in Pregnancy
*
(providing 250mg DHA (docosahexaenoic acid))
Daily Value not established
Vitamin A (as acetate and beta carotene) 1700 IU  21%
Vitamin C (as ascorbic acid) 60 mg 100%
Vitamin D3 (as cholecalciferol) 400 IU  100%
Vitamin E (as dl-alpha tocopheryl acetate) 30 IU  100%
Thiamine Mononitrate (Vitamin B1) 1.6 mg 94%
Riboflavin (Vitamin B2) 1.8 mg 90%
Niacin (as niacinamide) 15 mg 75%
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg 100%
Folic acid 1 mg 125%
Vitamin B12 (as cyanocobalamin)  5 mcg 63%
Elemental Iron (as polysaccharide iron complex) 29 mg 161%
Magnesium (as magnesium oxide) 25 mg 6%
Zinc (as zinc oxide) 15 mg 100%
Each Softgel Capsule contains
Algal oil blend
  (derived from crypthecodinium cohnii)
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.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

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

See package insert for full prescribing information

Manufactured for
EVERETT LABORATORIES, INC. Chatham, NJ 07928
1-877-324-9349

U.S. Patent No. 7,560,123; 8,101,587; 8,197,855 and 8,609,629
Select-OB® is a trademark of Everett Laboratories, Inc.
life'sDHA is a trademark of DSM.
U.S. Patent No. 7,163,811and 7,824,892
(Rev. 03/14)

(Rev. 03/14)

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 plant source DHA

New
Smaller DHA Softgel

DOES NOT CONTAIN
FISH OIL

life's DHA
HEALTHY BRAIN, EYES, HEART

Unit Dose Pack
30 Caplets and 30 Softgel Capsules

Rx

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 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)  
Berry (UNII: FV3431923Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Gelatin (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALIC ACID (UNII: 817L1N4CKP)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
TRIACETIN (UNII: XHX3C3X673)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
Hypromelloses (UNII: 3NXW29V3WO)  
Calcium Phosphate, Dibasic, Anhydrous (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 Glycols (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 (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)

Revised: 8/2017
Document Id: 1fb44ddb-b983-4153-b015-3b0bf7a3dfde
Set id: cb5c567a-8733-4004-832e-de8132b8da9e
Version: 3
Effective Time: 20170809
 
Exeltis USA, Inc.