Label: OBTREX ONE- calcium ascorbate dihydrate, cholecalciferol, d-alpha tocopheryl acetate, pyridoxine hydrochloride, calcium l-5-methyltetrahydrofolate, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, docosahexaenoic acid capsule, gelatin coated

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated February 3, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • STATEMENT OF IDENTITY

     Supplement Facts
     Serving Size: 1 Softgel / Servings Per Container: 30

    Amount

    Per Serving

    % Daily

    Value**

     Vitamin C (as calcium ascorbate dihydrate)18 mg 15% 
     Vitamin D (as cholecalciferol)6.25 mcg 42% 
     Vitamin E (as d-alpha tocopheryl acetate)10 mg 53% 
     Vitamin B6 (as pyridoxine HCl)30 mg 1500% 
     Folate (as calcium L-5-methyltetrahydrofolate) (1mg folate)1.7 mg DFE 283% 
     Vitamin B12 (as cyanocobalamin)15 mcg 536% 
     Iron (as carbonyl iron)38 mg 141% 
     Magnesium (as magnesium oxide)15 mg 4% 
     Zinc (as zinc oxide)20 mg 154% 
     DHA (Docosahexaenoic Acid from Algal Oil)225 mg 
     * Daily Value not established.
     ** Daily Value for Pregnant and Lactating Women.

    OTHER INGREDIENTS:

    Gelatin capsule (bovine gelatin, glycerin, purified water, titanium dioxide, FD&C Red #40, FD&C Blue #1), soy lecithin, white beeswax.

    To report a serious adverse event or to obtain product information contact (866) 703-3508.

    For lot number and expiration date, please see bottom of the box.

    Rev.: 05/22 Code#: PRO144-31TUC

    DESCRIPTION:

    OBTREX™ ONE is a premium prenatal vitamin and mineral supplement with DHA taken throughout pregnancy and during the postnatal periods for both lactating and non-lactating mothers. OBTREX™ ONE is also useful in improving nutritional status prior to conception. It is recommended that folate levels be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy. †

  • WARNINGS

    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.

    DO NOT USE OBTREX™ ONE if you have a known hypersensitivity to any of the ingredients within. This product is not intended for children under 12 years of age.

    WARNING:

    Ingestion of more than 3 grams per day of Omega-3 fatty acids, such as DHA (docosahexaenoic acid) has been shown to have potential anti-thrombotic effects, including increased bleeding times. Talk to your doctor if you are concerned about the effects of the DHA in OBTREX™ ONE especially if you are taking anticoagulants.

  • CAUTION:

    This product contains 1.7mg DFE (1mg) folic acid, the maximum safe Reference Daily Intake (RDI) amount for this nutrient. Folic Acid alone should not be used for individuals with pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in amounts above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    ADDITIONAL INFORMATION:

    Product contains FASTER Act of 2021 allergen: Soy. Product contains bio-engineered (BE) ingredient.

    ADVERSE REACTIONS:

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

  • DIRECTIONS FOR USE:

    Take One (1) Softgel Daily with or without food or as recommended by your healthcare provider.

  • OTHER INFORMATION:

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from extreme temperatures. Freezing & excessive heat may damage softgels.

     † These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • HEALTH CLAIM

    Dietary Supplement

    PREMIUM PRENATAL MULTI-VITAMIN WITH DHA

    with 100% Bioactive Folate

    FINALLY, A PRENATAL YOU CAN STOMACH!

    PRODUCT BENEFITS

    L-Methylfolate - (5-MTHF) a better form of folic acid

    Carbonyl Iron – slow release, 98% pure, high bioavailability

    Plant based DHA – no fishy ‘burp backs’

    Vitamin B6 – to help relieve morning sickness and minimize fatigue

    Non-constipating formula – changing hormone levels in early pregnancy cause constipation

    Small Softgel — easy to swallow, reduces gag reflex

    OBTREX™ ONE was specifically formulated to help reduce some of the unpleasant side effects associated with pregnancy and prenatal vitamin supplementation, while providing the latest in prenatal nutrition.

    Manufactured in the USA for:
    Pronova Corporation
    Miami, Florida 33155

  • Packaging

    Obstrex1

  • INGREDIENTS AND APPEARANCE
    OBTREX ONE 
    calcium ascorbate dihydrate, cholecalciferol, d-alpha tocopheryl acetate, pyridoxine hydrochloride, calcium l-5-methyltetrahydrofolate, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, docosahexaenoic acid capsule, gelatin coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:67555-144
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID18 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL6.25 ug
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE30 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON38 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE15 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT225 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:67555-144-313 in 1 BOX
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement03/30/2023
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)14 mm
    scoring1
    Labeler - Pronova Corporation (111421496)