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Select-OB

Generic Name: beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium and zinc
Dosage Form: tablet, chewable

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.

Select-OB®
Prenatal Supplement

Rx only

COMPOSITION

Each caplet contains:
Vitamin A 1,700 IU
Vitamin C 60 mg
Vitamin D 400 IU
Vitamin E 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
Elemental Iron (as polysaccharide iron complex) 29 mg
Magnesium (as magnesium oxide) 25 mg
Zinc (as zinc oxide) 15 mg

Other Ingredients: 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.

Indications and Usage for Select-OB

Select-OB® is indicated to provide vitamin, mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

Contraindications

Select-OB® 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 (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 the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS

Select-OB® 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 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. 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®.

Select-OB Dosage and Administration

Before, during and after pregnancy, one caplet daily, or as directed by a physician.

How is Select-OB Supplied

Select-OB® is available as a light blue caplet debossed EV0077. Available in bottle of 90, (NDC 0642-0077-90).

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

Rx only

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
Select-OB® is a trademark of
Everett Laboratories, Inc.

Rev. 03/13
6876

PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label

NDC 0642-0077-90

Select-OB®
Prenatal Supplement

90 Caplets
Rx only

SELECT OB 
.beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium, and zinc tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0077
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.Beta.-Carotene (.Beta.-Carotene) .Beta.-Carotene 600 [iU]
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1100 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg
CHOLECALCIFEROL (Cholecalciferol) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.6 mg
Riboflavin (Riboflavin) Riboflavin 1.8 mg
Niacin (Niacin) Niacin 15 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 0.4 mg
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 0.6 mg
Cobalamin (Cobalamin) Cobalamin 5 ug
Iron (Iron) Iron 29 mg
Magnesium (Magnesium) Magnesium 25 mg
Zinc (Zinc) Zinc 15 mg
Inactive Ingredients
Ingredient Name Strength
FRUCTOSE  
STEARIC ACID  
CROSCARMELLOSE SODIUM  
MALTODEXTRIN  
HYPROMELLOSES  
SILICON DIOXIDE  
CITRIC ACID MONOHYDRATE  
TITANIUM DIOXIDE  
POLYDEXTROSE  
MAGNESIUM STEARATE  
MALIC ACID  
HYDROXYPROPYL CELLULOSE (TYPE H)  
TRIACETIN  
STARCH, CORN  
SUCROSE  
ACACIA  
POLYETHYLENE GLYCOLS  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
SODIUM ASCORBATE  
MEDIUM-CHAIN TRIGLYCERIDES  
.ALPHA.-TOCOPHEROL, DL-  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 19mm
Flavor BERRY Imprint Code EV0077
Contains         
Packaging
# Item Code Package Description
1 NDC:0642-0077-90 90 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/04/2005
Labeler - Everett Laboratories, Inc. (071170534)
Revised: 09/2014
 
Everett Laboratories, Inc.
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