OBSTETRIX 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

Obstetrix ONE by

Drug Labeling and Warnings

Obstetrix ONE by is a Other medication manufactured, distributed, or labeled by Seyer Pharmatec, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts	Amount	% Daily
Serving Size: 1 Softgel / Servings Per Container: 30	Per Serving	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	284%
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.

Manufactured in the USA for:

Seyer Pharmatec, Inc 
Caguas, Puerto Rico 00725

To report a serious adverse event or to obtain product information, contact (888) 444-5072.

DESCRIPTION: Obstetrix™ One is a prenatal vitamin and mineral supplementation with DHA taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers. Obstetrix™ One is also useful in improving nutritional status prior to conception. It is recommended that for all women folate levels should be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy.†

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

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 Obstetrix™ One with individuals that have a known hypersensitivity to any of the ingredients. This product is not for use in children under 12 years of age. 

CAUTION:

This product contains 1 mg 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 progress. 

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. Administration of Obstetrix™ One should be avoided in patients taking anticoagulants.

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:

One Softgel Daily with or without food or as prescribe by your healthcare provider

OTHER INFORMATION:

Obstetrix™ One is supplied in child resistant bottles of 30 softgels and sample bottles of 7 softgels. 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 the softgels

HEALTH CLAIM

Dietary Supplement

Prenatal Multi-Vitamin

with 100% Bioactive Folate

Plant Based DHA

Packaging

INGREDIENTS AND APPEARANCE

OBSTETRIX 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:11026-2630
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	1.7 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:11026-2630-3	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		02/13/2023

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

Labeler - Seyer Pharmatec, Inc. (832947126)