Select-OB +DHA

Product Overview

Brand: Everett Laboratories

Net Contents: N/A

Serving Size (Overview): 1 Caplet(s)

Product Type: Other Combinations [A1325]

Form: Other (e.g. tea bag) [E0172]

Date Entered: Dec 24, 2013

Market Status: On Market

Suggested Use (Overview): INDICATIONS AND USAGE: SELECT-OB(R)+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 individuals with known allergies to fish. SELECT-OB(R)+DHA does not contain fish; fish oils; fish proteins or fish byproducts. DOSAGE AND ADMINISTRATION: Before; during and after pregnancy; chew or swallow one blue SELECT-OB(R) caplet and swallow one DHA gel capsule daily; or as directed by a physician.

Product Self-Roles:

No specific self-roles defined.

Dietary Supplement Facts

Ingredient	Category	Amount Per Serving	Unit	% Daily Value	Target Group	Serving Size (Fact)
Vitamin A	vitamin	1700	IU	N/A	N/A	1 Caplet(s)
Vitamin C	vitamin	60	mg	N/A	N/A	1 Caplet(s)
Vitamin D3	vitamin	400	IU	N/A	N/A	1 Caplet(s)
Vitamin E	vitamin	30	IU	N/A	N/A	1 Caplet(s)
Thiamine Mononitrate	vitamin	1.6	mg	N/A	N/A	1 Caplet(s)
Riboflavin	vitamin	1.8	mg	N/A	N/A	1 Caplet(s)
Niacin	vitamin	15	mg	N/A	N/A	1 Caplet(s)
Vitamin B6	vitamin	2.5	mg	N/A	N/A	1 Caplet(s)
Folic Acid	vitamin	1	mg	N/A	N/A	1 Caplet(s)
Vitamin B12	vitamin	5	mcg	N/A	N/A	1 Caplet(s)
Iron	mineral	29	mg	N/A	N/A	1 Caplet(s)
Magnesium	mineral	25	mg	N/A	N/A	1 Caplet(s)
Zinc	mineral	15	mg	N/A	N/A	1 Caplet(s)
Each DHA capsule provides:	other	N/A	N/A	N/A	N/A	1 Caplet(s)
Omega-3 Fatty Acid:	other	N/A	N/A	N/A	N/A	1 Caplet(s)
Docosahexaenoic Acid	fatty acid	250	mg	N/A	N/A	1 Caplet(s)
Lauric Acid	fatty acid	20	mg	N/A	N/A	1 Caplet(s)

Other Ingredients

Fructose; Stearic Acid (C18:0); Croscarmellose Sodium; gelatin; Silicon Dioxide (SiO2); Hydroxypropyl Cellulose; Magnesium Stearate; Hypromellose; Soy Oil; Citric Acid; Maltodextrin; Titanium Dioxide; Polydextrose; Triacetin; Polyethylene Glycol; FD&C Blue No. 1 Aluminum Lake; FD&C Blue No. 2 Aluminum Lake; Glycerin; Mixed Berry flavor; Orange flavor; Water

Label Statements

Precautions

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. WARNINGS/PRECAUTIONS:SELECT-OB(R)+DHA should be used with caution in patients with known sensitivity or allergy to soy. ADVERSE RECTIONS: Advers reactions have been reported with specinc vitamins and minerals but generally at doses substantially higher than those in SELECT-OB(R)+DHA. However allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments gastrointestinal complaints glucose abnormalities and visual problems. Rx only CONTRAINDICATIONS: SELECT-OB(R)+DHA is contraindicated in patients with hypersensitivity to any of its components. Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia and in those with anaphylactic sensitivity to folic acid. lron 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). 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 pemicious 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 B-12 deficiency. Consumption of more than 3 grams of omega~3 fatty acids per day from all sources may lead to exoessive bleeding. Supplemental intake of omega—3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage. Keep out of reach of children. Drug Interactions: High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine fosphenytoin phenytoin phenobarbitol valproic acld. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercaloemia 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; taken 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.

Product Specific Information

Store at room temperature approximately 15(0)-30(0)C (59(0)-86(0)F) avoid excessive heat.

Branding Statement(s)

U.S. Patent No. 7560123; 5407957; 5492938; 7163811 and other patents pendingSelect-OB(R) is a trademark of Everett Laboratories Inc.

Product/Version Code

(Rev. 09/11)

Suggested Use

INDICATIONS AND USAGE: SELECT-OB(R)+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 individuals with known allergies to fish. SELECT-OB(R)+DHA does not contain fish fish oils fish proteins or fish byproducts. DOSAGE AND ADMINISTRATION: Before during and after pregnancy chew or swallow one blue SELECT-OB(R) caplet and swallow one DHA gel capsule daily or as directed by a physician.

Other

DESCRIPTIDN: 30 SELECT-OB(R) caplets and 30 DHA capsules are co-packaged in child-resistant blister cards for prescription use. SELECT-OB(R) is a light blue caplet imprint 'EV0O77'. DHA is contained in an amber-colored gelatin capsule. HOW SUPPLIED: Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 Select-OB(R) caplets and 5 DHA gel capsules each) (NDC 06420075-30). Prenatal Supplement with DHA