SELECT OB- .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

.Beta.-Carotene (UNII: 01YAE03M7J) (.Beta.-Carotene - UNII:01YAE03M7J), VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T), Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM297

Available from:

Everett Laboratories, Inc.

INN (International Name):

.Beta.-Carotene

Composition:

.Beta.-Carotene 600 [iU]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 ).

Product summary:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

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
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
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 B )
1.6 mg
Riboflavin (Vitamin B )
1.8 mg
Niacin (as niacinamide)
15 mg
Vitamin B (as pyridoxine hydrochloride)
2.5 mg
Folic Acid
1 mg
Vitamin B
(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
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