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 
GM Pharmaceuticals, Inc.

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.

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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 mg167%167%
Vitamin D3 (as Cholecalciferol)400 IU100%100%
Vitamin E (as D-Alpha-Tocopheryl)30 IU100%100%
Thiamin (Vitamin B1)2 mg133%118%
Riboflavin (Vitamin B2)4 mg235%200%
Vitamin B6 (as Pyridoxine HCl)20 mg1000%800%
Folic Acid1 mg250%125%
Vitamin B12 (as Cyanocobalamin)30 mcg500%375%
Iron (as Carbonyl Iron)20 mg111%111%
Zinc (as Zinc Oxide)30 mg200%200%
Copper (as Cupric Sulfate)2 mg100%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 B 12 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 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.

PRINCIPAL DISPLAY PANEL - 30 Softgels Bottle Label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58809-287
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN30 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT320 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE2 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code OB01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-287-301 in 1 CARTON10/28/201303/31/2017
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/28/201303/31/2017
Labeler - GM Pharmaceuticals, Inc. (793000860)

Revised: 10/2017
 
GM Pharmaceuticals, Inc.