PRINCIPAL DISPLAY PANEL - Kit Carton

0642-0075-30

Select-OB+DHA ®

Prenatal Supplement with DHA

Berry flavored BLUE Select-OB ® Caplet
can be chewed or swallowed

DHA Softgel Capsule

from natural source DHA

Smaller DHA Softgel

DOES NOT CONTAIN
FISH OIL

R X

Unit Dose Pack

30 Caplets and 30 Softgel Capsules

U.S. Patented

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.

INDICATIONS AND USAGE

Select-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.*

Select-OB+DHA ® does not contain fish, fish oils, fish proteins or fish byproducts.

CONTRAINDICATIONS

Select-OB+DHA ® 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 (vitaminB12).

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Select-OB+DHA ®.

WARNINGS/PRECAUTIONS

Select-OB+DHA ® 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 rick of heart disease can occur. Prolonged use of iron slats 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.

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.

DOSAGE AND ADMINISTRATION

Before, during and after pregnancy, chew or swallow one blue Select OB ® caplet and swallow one DHA softgel capsule daily, or as directed by a physician.

HOW SUPPLIED

Select-OB+DHA ® is available as a light blue caplet debossed EV0077 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 SELECT-OB ® caplets and 6 DHA softgel capsules each) (0642-0075-30) and as professional samples (0642-0075-03).

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

Rx

Distributed by:

** Exeltis USA, Inc.**

** Florham Park, NJ 07932**

1-877-324-9349

www.exeltisusa.com

©2023 Exeltis USA, Inc. All rights reserved.

U.S. Patent No. 7,560,123; 8,101,587; 8,197,855; and 8,609,629

Select-OB+DHA ® is a trademark of Exeltis Healthcare, S.L.

Rev. January 2023 0753001-02

COMPOSITION

Other Ingredients in Select-OB ® caplet: 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

Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.