OBTREX DHA COMBO PACK- docosahexaenoic acid, beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate kit

OBTREX DHA Combo Pack by

Drug Labeling and Warnings

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

Drug Details [pdf]

OBTREX DHA Softgels

Supplement Facts
Serving Size: 1 Softgel / Servings Per Container: 30
	Amount	% Daily
	Per Serving	Value
DHA (docosahexaenoic acid)	350 mg	*
* % Daily Value not established.

OTHER INGREDIENTS:

Gelatin, Glycerine, Purified Water, Sodium Alginate, Stearic Acid. This product contains purified fish oil.

OBTREX™ DHA Omega-3 Fatty Acids are manufactured under cGMP, CFIA and HACCP standards and are also in compliance with the Global Organization of DHA Omega-3 standards.

INDICATIONS: 

OBTREX™ DHA combination pack is indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers. OBTREX™ DHA combination pack is also useful in improving nutritional status prior to conception.†

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

DOSAGE AND ADMINISTRATION:

One softgel daily; before, during and after pregnancy, with or without food, or as directed by a physician.

PRECAUTIONS:

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 OBTREX™ DHA Omega-3 Fatty Acids should be avoided in patients taking anticoagulants.

Sold in combination with OBTREX™ DHA Prenatals

STORAGE:

Store at room temperature, USP

Keep out of the reach of Children

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

Rev 10/20

HEALTH CLAIM

Dietary Supplement

ENTERIC COATED TO HELP PREVENT BURP BACK

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

OBTREX DHA Caplets

Supplement Facts
Serving Size: 1 Caplet / Servings Per Container: 30
	Amount Per Serving	% Daily Value**
Vitamin A (as Beta Carotene)	810 mcg	62%
Vitamin C (as Ascorbic Acid)	120 mg	100%
Vitamin D (as Cholecalciferol)	10 mcg	67%
Vitamin E (as dl-Alpha Tocopheryl Acetate)	8.1 mg	43%
Thiamin (as Thiamine HCl)	3 mg	214%
Riboflavin	3.4 mg	213%
Niacin (as Niacinamide)	20 mg	111%
Vitamin B6 (as Pyridoxine HCl)	40 mg	2000%
Folate (as L-5-Methyltetrahydrofolate Calcium)	1700 mcg DFE	283%
	(1000 mcg Folic Acid)
Vitamin B12 (as Cyanocobalamin)	12 mcg	429%
Iron (as Carbonyl Iron)	29 mg	107%
Magnesium (as Magnesium Oxide)	30 mg	8%
Zinc (as Zinc Oxide)	25 mg	192%
Selenium (as Sodium Selenate)	65mcg	93%
* Daily Value (DV) for Pregnant and Lactating Women.

OTHER INGREDIENTS:

Microcrystalline Cellulose, Methacrylic Acid Copolymer, Croscarmellose Sodium, Gelatin, Stearic Acid, Hypromellose, Maltodextrin, Crospovidone, Starch, Silica, Titanium Dioxide, Triacetin, Sucrose, Citric Acid, Magnesium Stearate, Sodium Lauryl Sulfate, Polyvinylpyrrolidone, Soy Polysaccharide, Mineral Oil, Riboflavin, FD&C Yellow #6 Lake, Sodium Ascorbate, Polyethylene Glycol, Trisodium Citrate, Tocopherols, Tricalcium Phosphate, Glycerol Monostearate, Triethyl Citrate, Ascorbyl Palmitate, Triglycerides, Sodium Benzoate, Polysorbate 80, Sorbic Acid and Talc. Contains soy.

DESCRIPTION: 

OBTREX™ DHA combination pack is indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers.

OBTREX™ DHA combination pack is also useful in improving nutritional status prior to conception.†

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

DOSAGE AND ADMINISTRATION:

One caplet daily or as directed by a physician.

CONTRAINDICATIONS: 

OBTREX™ DHA is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient

PRECAUTIONS:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

ADVERSE REACTIONS:

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

STORAGE:

Store at room temperature, USP.

Keep out of the reach of Children

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

Rev 10/20

HEALTH CLAIM

Dietary Supplement

with 100% Bioactive Folate

ENTERIC COATED, WELL TOLERATED, AND EASY TO SWALLOW.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

OBTREX DHA Combo Pack

DOSAGE AND ADMINISTRATION:

Take one caplet and one softgel daily or as directed by your healthcare provider.

HOW SUPPLIED:

OBTREX™ DHA: is available as a combination pack, which contains: Bottle of 30 DHA translucent soft gels and a Bottle of 30 orange, oval shaped tablets with imprinted “OBX” Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.

HEALTH CLAIM

Dietary Supplement

THE SMALL, WELL-TOLERATED PRENATAL DUO FORMULATED TO ENSURE COMPLIANCE.†

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

Packaging

INGREDIENTS AND APPEARANCE

OBTREX DHA COMBO PACK 
docosahexaenoic acid, beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate kit

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:67555-143

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:67555-143-60	1 in 1 BOX

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	30
Part 2	1 BOTTLE	30

Part 1 of 2

OBTREX DHA SOFTGEL 
docosahexaenoic acid capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	350 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FISH OIL (UNII: XGF7L72M0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/24/2023

Part 2 of 2

OBTREX DHA CAPLET 
beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	810 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	8.1 mg
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	40 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	29 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	30 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70)	SELENIUM	65 ug

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
STARCH, RICE (UNII: 4DGK8B7I3S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SOYBEAN COTYLEDON CELL WALL POLYSACCHARIDES (UNII: 4UL6DF56YQ)
MINERAL OIL (UNII: T5L8T28FGP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM ASCORBATE (UNII: S033EH8359)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBIC ACID (UNII: X045WJ989B)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/24/2023

Labeler - Pronova Corporation (111421496)