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Active OB

Generic Name: corbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, zinc oxide, cupric sulfate and doconexent
Dosage Form: capsule, liquid filled

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.

Active OB™

Supplement Facts
Serving Size: 1 Softgel
Servings per container: 30
Amount per Serving: % Daily Value % Daily Value for Lactating Women
*
Daily Values (DV) not established.
Vitamin C (as Ascorbic Acid) 100 mg 167% 167%
Vitamin D3 (as Cholecalciferol) 400 IU 100% 100%
Vitamin E (as D-Alpha-Tocopheryl) 30 IU 100% 100%
Thiamin (Vitamin B1) 2 mg 133% 118%
Riboflavin (Vitamin B2) 4 mg 235% 200%
Vitamin B6 (as Pyridoxine HCl) 20 mg 1000% 800%
Folic Acid 1 mg 250% 125%
Vitamin B12 (as Cyanocobalamin) 30 mcg 500% 375%
Iron (as Carbonyl Iron) 20 mg 111% 111%
Zinc (as Zinc Oxide) 30 mg 200% 200%
Copper (as Cupric Sulfate) 2 mg 100% 100%
Docosahexaenoic Acid (DHA) 320 mg * *

Active OB™ contains fish oil, soy, and bovine gelatin.

OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Soy Lecithin, Natural Orange Flavor, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Blue #1.

Professional Labeling

INDICATIONS

Active OB™ is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Active OB™ can also be beneficial in improving the nutritional status of women prior to conception.1

1
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

Contraindications

Active OB™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential 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.

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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.

Adverse Reactions

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

DIRECTIONS

Adults

Take one softgel daily with or without food, or as prescribed by a licensed medical practitioner.

Children under 12

Consult a doctor.

Do not exceed the recommended dose.

How is Active OB Supplied

Active OB™ is supplied as purple softgel capsules with imprint "OB01" in child-resistant bottles containing 30 softgels. (58809-287-30).

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

KEEP CARTON FOR REFERENCE.

Manufactured for:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

Made in Canada

Active OB (™) should be administered under the supervision of a licensed medical practitioner.

Protect from light and moisture.

Keep out of reach of children.

To report adverse side effects or to obtain product information, contact GM Pharmaceuticals at 1-888-535-0305.

Covered by U.S. Patent #8263137

Rev. 09/2013

PRINCIPAL DISPLAY PANEL - 30 Softgels Bottle Label

58809-287-30

Active OB

Prenatal Vitamin
Supplement

GMPharmaceuticals, Inc.

30 Softgels
Rx

Manufactured for:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

Lactose, Gluten and Sugar Free

Contains fish oil, soy,
and bovine gelatin.

KEEP OUT OF REACH OF CHILDREN
Protect from light and moisture.

Active OB 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, zinc oxide, cupric sulfate, and doconexent capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58809-287
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 30 ug
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 20 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 30 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 2 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 320 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
YELLOW WAX  
LECITHIN, SOYBEAN  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
ETHYL VANILLIN  
FD&C BLUE NO. 1  
Product Characteristics
Color PURPLE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code OB01
Contains         
Packaging
# Item Code Package Description
1 NDC:58809-287-30 1 BOTTLE, PLASTIC in 1 CARTON
1 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/28/2013
Labeler - GM Pharmaceuticals, Inc. (793000860)
Revised: 11/2013
 
GM Pharmaceuticals, Inc.
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