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 
Pronova Corporation

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OBTREX ONE

 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. †

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.

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

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)

Revised: 2/2023
Document Id: 2588f9cc-47d4-400f-bc58-42fa7f0df13d
Set id: 430eb254-39a3-4642-95b5-17009a2610b5
Version: 1
Effective Time: 20230203
 
Pronova Corporation