BOXED WARNING SECTION.
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label NDC 0642-0077-90 Select-OB Prenatal Supplement 90 Caplets Rx only
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in SELECT-OB.
INDICATIONS & USAGE SECTION.
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.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION Before, during and after pregnancy, one caplet daily, or as directed by a physician.
SPL UNCLASSIFIED SECTION.
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
HOW SUPPLIED SECTION.
HOW 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 15-30C (59-86F), avoid excessive heat and moisture.
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.
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.
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).
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.