Choice OB DHA
Choice - OB + DHA
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Rx Only
SUPPLEMENT FACTS
Each tablet contains:
| A (acetate and beta carotene) | 1700 IU |
| D3 (cholecalciferol) | 400 IU |
| C (ascorbic acid) | 60 mg |
| E (dl-alpha tocopheryl acetate) | 30 IU |
| Folic Acid (Pterolyglutamic Acid) | 1 mg |
| B1 (thiamine mononitrate) | 1.6 mg |
| B2 (riboflavin) | 1.8 mg |
| B6 (pyridoxine hydrochloride) | 2.5 mg |
| B12 (cyanocobalamin) | 5 mcg |
| Niacin (niacinamide) | 15 mg |
| Iron (polysaccharide iron complex) | 29 mg |
| Magnesium (magnesium oxide) | 25 mg |
| Zinc (zinc oxide) | 15 mg |
| Each softgel capsule contains: | |
| Docosahexaenoic Acid (DHA) | 250 mg |
| Lauric Acid | 20 mg |
OTHER INGREDIENTS (softgel): bovine gelatin, glycerin USP and water.
DHA is an omega-3 fatty acid contained in oil derived from microalgea.
OTHER INGREDIENTS (tablet): cherry flavor, citric acid, crossacarmelose sodium, fructose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sorbitol, stevia and strawberry flavor.
Uses
INDICATIONS: Choice - OB + DHA is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy and during the postnatal period for the lactating and non-lactating mother, including those individuals with known allergies to fish. Choice - OB + DHA does not contain fish, fish oils, fish proteins or fish byproducts.
CONTRAINDICATIONS: Folic acid (pteroylglutamic 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). Resistance to treatment may be due to depressed hematopoiesis, alcoholism, the presence of anti-metabolic drugs and to deficiencies of vitamins. Prolonged use of iron salts may produce iron storage disease.
WARNING: Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of pernicious anemia, it does not ameliorate the attendant neurologic involvement.
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 poison control center immediately.
PRECAUTIONS: Folic acid, especially in doses over 0.1 mg daily, may obscure pernicious anemia associated with vitamin B12 deficiency in that hematologic remission may occur while neurological manifestations remain progressive. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Consumption of greater than 3 grams per day of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.
INFORMATION FOR PATIENTS: Patients should be informed to disclose all medicines, vitamins and supplements used and to take the prescribed dose. Overdose or interactions can lead to side effects including birth defects.
ADVERSE REACTIONS: Allergic sensitivity reactions and gastrointestional disturbances may occur.
DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one gel capsule daily,or as directed by a physician.
HOW SUPPLIED: 42192-353-60. Choice - OB + DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 tablet and 1 golden - colored DHA softgel capsule equals 1 daily dose). Each dispensing carton contains 5 cards with 6 unit-doses per card which is a 30-day supply. The beige oval tablet is imprinted with “353” on one side and is blank on the other. The golden - colored DHA softgel capsule is not imprinted. The listed product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802
Rev 0313
PRINCIPAL DISPLAY PANEL - 30 tablets
42192-353-60
Choice - OB + DHA
Prenatal/Multivitamin Tablets
that can be Chewed or Swallowed
and Omega-3 (DHA) Gelcaps
Rx Only
Natural berry flavored tablet
30 day supply - 30 tablets and 30 softgel capsules
Acella
PHARMACEUTICALS, LLC
Choice OB DHA.beta.-carotene, cholecalciferol, ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent KIT
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