Ultimate OB DHA description, usages, side effects, indications, overdosage, supplying and lots more!

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Ultimate OB DHA

TRIGEN Laboratories, Inc.

Ultimate OB DHA


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Supplement Facts
Serving Size: 1 Tablet & 1 Softgel Capsule
Servings Per Box: 30
Each Tablet contains % Daily Value in Pregnancy
Vitamin D3 (cholecalciferol) 400 IU 200%Calculated based on Calciferol
Vitamin E (dl-alpha tocopheryl succinate) 10 IU  44%
Vitamin B1 (thiamine mononitrate) 1.5 mg 107%
Vitamin B2 (riboflavin) 1.6 mg 114%
Vitamin B3 (niacinamide) 17 mg 94%
Vitamin B6 (pyridoxine HCl) 50 mg 2632%
Folic Acid 1 mg 167%
Vitamin B12 (cyanocobalamin) 12 mcg 462%
Biotin 30 mcg 100%
Iron
  (polysaccharide iron complex) 22 mg 81%
  (ferrous aspartate and ferrous glycinate) 6 mg Daily Value not established   
Iodine (potassium iodide) 175 mcg 80%
Zinc (zinc oxide) 15 mg 136%
Selenium (sodium selenate) 65 mcg 0.10%
Copper (cupric sulfate) 0.8 mg 80%
Each Softgel Capsule contains % Daily Value in Pregnancy
Omega-3 Fatty Acid:
DHA from Fish Oil 200 mg Daily Value not established   

Inactive Ingredients (Tablet): Microcrystalline Cellulose, DiCalcium Phosphate, Crosecarmellose Sodium, Povidone K30, Acacia, Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Stearic Acid, Magnesium Stearate, Fumed Silica, Polyethylene Glycol, Talc.

Inactive Ingredients (Softgel Capsule): Vitamin E Oil, Gelatin, Glycerin, Purified Water.

ULTIMATE OB DHA INDICATIONS AND USAGE

Ultimate OB DHA is a prescription multivitamin/multimineral and Omega-3 fatty acid nutritional supplement indicated for use in improving the nutrtional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Ultimate OB DHA is also beneficial in improving the nutritional status of women prior to conception.

ULTIMATE OB DHA CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Ingestion of more than 3 grams of omega-3 fatty scids per day has been shown to have antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis.

THIS PRODUCT CONTAINS FISH OIL.

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 poison control center immediately.

PRECAUTIONS

Folic Acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of Vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

ULTIMATE OB DHA ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

ULTIMATE OB DHA DOSAGE AND ADMINISTRATION

One tablet and one softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

HOW SUPPLIED

Ultimate OB DHA is supplied in six child-resistant blister cards of 5 tablets and 5 softgel capsules per card. The prenatal vitamin is a white, oval multivitamin/mineral tablet debossed with "TL505" on one side. The essential fatty acid DHA capsule is a clear, oblong soft gelatin capsule containing pale yellow oil.

Product Code 13811-505-30

STORAGE

Store at controlled room temperature 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature].

Contact with moisture can discolor or erode the tablet.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF REACH OF CHILDREN.

Rx Only.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 02/12

PRINCIPAL DISPLAY PANEL - Kit Carton

13811-505-30
Rx Only

Ultimate OB DHA

Prenatal Vitamin Tablets & 200mg DHA Softgel Capsule

30 Day Supply

30 tablets and 30 softgel capsules

TRIGEN
LABORATORIES

Ultimate OB DHA

Ultimate OB DHA

cholecalciferol, .ALPHA.-TOCOPHEROL SUCCINATE, D-, thiamine mononitrate, riboflavin, niacinamide, PYRIDOXINE HYDROCHLORIDE, folic acid, cyanocobalamin, biotin, iron, ferrous aspartate, ferrous bisglycinate, potassium iodide, zinc oxide, sodium selenate, cupric sulfate, and DOCONEXENT KIT

Product Information

Product Type Dietary supplement Item Code (Source) NDC:13811-505
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-505-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-07-01


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