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, chewable 
Everett Laboratories, 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® Chewable Caplets
Prenatal Supplement

Supplement Facts
Serving Size 1 Caplet
Each Caplet contains % Daily Value
Vitamin A (as beta carotene and acetate) 1700  IU 21%
Vitamin C (as ascorbic acid) 60  mg 100%
Vitamin D (as cholecalciferol) 400  IU 100%
Vitamin E (as dl-alpha tocopheryl acetate) 30  IU 100%
Thiamin (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%
Folate (as Folic acid USP 0.4 mg and
  L-methylfolate calcium 0.6 mg)
mg 125%
Vitamin B12 (as cobalamin) mcg 63%
Iron (as polysaccharide iron complex) 29  mg 161%
Magnesium (as magnesium oxide) 25  mg 6%
Zinc (as zinc oxide) 15  mg 100%

Other Ingredients: Fructose, stearic acid, mono and diglycerides of edible fatty acids, croscarmellose sodium, natural berry flavor, modified food starch, maltodextrin, hydroxypropylmethylcellulose, silicon dioxide, citric acid, titanium dioxide (as color), polydextrose, magnesium stearate, malic acid, hydroxypropylcellulose, triacetin, corn starch, sucrose, acacia, polyethylene glycol, dibasic calcium phosphate, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, dl-alpha-tocopheryl.

CONTRAINDICATIONS

SELECT-OB® Chewable Caplets are 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 (vitamin B12).

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

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 risk of heart disease can occur. Prolonged use of iron salts 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.

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; carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid. Folic acid may decrease a patient's response to methotrexate. 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.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in SELECT-OB® Chewable Caplets. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

HOW SUPPLIED

SELECT-OB® Chewable Caplets are available as a light blue, caplet debossed "EV0120". Available in bottle of 90 and as professional samples.

Rx

USAGE

SELECT-OB® Chewable Caplets provide vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

DIRECTIONS FOR USE

Before, during and after pregnancy, chew or swallow one blue SELECT-OB® Chewable Caplet daily, or as directed by a physician.

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.

KEEP OUT OF REACH OF CHILDREN.

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

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

PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label

0642-0120-90

Select-OB®

Chewable Caplets
Prenatal Supplement

90 Caplets

Rx

PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
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, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0120
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)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALIC ACID (UNII: 817L1N4CKP)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
TRIACETIN (UNII: XHX3C3X673)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
ACACIA (UNII: 5C5403N26O)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
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)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 19mm
Flavor BERRY Imprint Code EV0120
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0642-0120-90 90 in 1 BOTTLE
2 NDC:0642-0120-03 3 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/14/2014
Labeler - Everett Laboratories, Inc. (071170534)

Revised: 7/2014
Document Id: 13fcc1c1-c176-4500-937e-be35b285c7c8
Set id: adc77b02-a00f-430b-ae61-f89387b6fe3b
Version: 1
Effective Time: 20140721
 
Everett Laboratories, Inc.