FDA Label for Select Ob
View Indications, Usage & Precautions
Select Ob Product Label
The following document was submitted to the FDA by the labeler of this product Everett Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
| 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) | 1 | mg | 125% |
| Vitamin B12 (as cobalamin) | 5 | 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.
Other
KEEP OUT OF REACH OF CHILDREN.
Manufactured for:
EVERETT LABORATORIES, INC.
Chatham, NJ 07928
1-877-324-9349
Storage And Handling
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.
Principal Display Panel - 90 Caplet Bottle Label
0642-0120-90
Select-OB®
Chewable Caplets
Prenatal Supplement
90 Caplets
Rx
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