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Choice OB + DHA

Generic Name: prenatal multivitamin
Dosage Form: tablet

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.

Choice - OB + DHA

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.

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-353
Packaging
# Item Code Package Description
1 NDC:42192-353-60 30 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 1 KIT (KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 30 
Part 2 30 
Part 1 of 2
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 tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 1700 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.6 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.8 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2.5 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 5 ug
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 ug
IRON SUCROSE (FERRIC CATION) FERRIC CATION 29 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
CROSCARMELLOSE SODIUM  
FRUCTOSE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
SORBITOL  
STEVIA REBAUDIUNA LEAF  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 15mm
Flavor CHERRY, STRAWBERRY Imprint Code 353
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/17/2013 07/31/2015
Part 2 of 2
DHA 
omega 3 fatty acids capsule, liquid filled
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
Inactive Ingredients
Ingredient Name Strength
LAURIC ACID  
GELATIN  
GLYCERIN  
WATER  
Product Characteristics
Color YELLOW (golden) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 05/17/2013 07/31/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/17/2013 07/31/2015
Labeler - Acella Pharmaceuticals, LLC (825380939)
Revised: 03/2014
 
Acella Pharmaceuticals, LLC



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