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

OBTREX ONE by

Drug Labeling and Warnings

OBTREX ONE by is a Other medication manufactured, distributed, or labeled by Pronova Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 L-5-methylfolate, calcium salt) - Metafolin® (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, annatto, and sodium copper chlorophyllin), sunflower lecithin, white beeswax.

Metafolin® is a registered trademark of Merck KGaA, Darmstadt Germany.

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.
Revised 01/2024 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: Potential discoloration and/or darkening on capsules or capsule seams may occur immediately or overtime, due to the Vitamin C and Iron. Does not affect product efficacy.

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

NO ARTIFICIAL COLORANTS OR DYES

FINALLY, A PRENATAL YOU CAN STOMACH!

PRODUCT BENEFITS

Metafolin® - increases plasma folate more effectively than 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, All-in-One Softgel — easy to swallow, well-tolerated

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

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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:67555-144
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	18 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	6.25 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 HYDROCHLORIDE	30 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	15 ug
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	38 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	15 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	225 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ANNATTO (UNII: 6PQP1V1B6O)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:67555-144-31	3 in 1 BOX
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		03/30/2023

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	14 mm
scoring	1

Labeler - Pronova Corporation (111421496)