Label: WESNATAL DHA COMPLETE kit

  • NHRIC Code(s): 69367-251-30
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 13, 2023

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  • STATEMENT OF IDENTITY

    Multivitamin/Multimineral Tablet

    Supplement Facts
    Serving Size: Tablets
    Serving Per Container: 30
    Amount Per Serving% DV for Pregnant and Lactating Women
    *
    30 mg dl-Alpha Tocopheryl Acetate equivalent to 15 mg Alpha-Tocopherol
    Vitamin A
    (as Beta-Carotene)    		900 mcg RAE
    (3000 IU)    		69%
    Vitamin C
    (Abscorbic Acid)    		120 mg100%
    Vitamin D
    (as Cholecalciferol)    		10 mcg
    (400 IU)    		67%
    Vitamin E
    (as dl-Alpha Tocopheryl Acetate)    		15 mg*79%
    Thiamin
    (as Thiamine Mononitrate)    		1.8 mg129%
    Riboflavin4 mg250%
    Niacin
    (as Niacinamide)    		20 mg NE111%
    Vitamin B6
    (as Pyridoxine HCl)    		25 mg1250%
    Folate1667 mcg DFE
    (1000 mcg Folic Acid)    		278%
    Vitamin B12
    (as Cyanocobalamin)    		12 mcg429%
    Calcium
    (as Calcium Carbonate)    		200 mg15%
    Iron
    (from Ferrous Bisglycinate and Iron Protein Succinylate)    		29 mg107%
    Magnesium
    (as Magnesium Oxide)    		25 mg6%
    Zinc
    (as Zinc Oxide)    		25 mg192%
    Copper
    (as Cupric Oxide)    		2 mg154%

    Omega-3 Fatty Acid Capsule

    Supplement Facts
    Serving Size: Softgel Capsule
    Serving Per Container: 30
    Amount Per Serving% DV for Pregnant and Lactating Women
    *
    Daily Value (DV) not established
    DHA (Docosahexaenoic Acid)200 mg*

    Other Ingredients: Tablets: Microcrystalline Cellulose, Croscarmellose Sodium, Tripotassium Citrate, Coating (Sodium Carboxymethylcellulose, Dextrin, Dextrose, Lecithin, Sodium Citrate), Acacia, Citric Acid, Povidone K30, Fumed Silica, Magnesium Stearate and Stearic Acid.

    Soft gelatin capsules: Bovine Gelatin, Glycerin, Water, and Ethyl Vanillin.

    THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVIES & SARDINES).

    WesNatal DHA Complete is a multivitamin/multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the post-natal period for both lactating and non-lactating mothers.

  • CONTRAINDICATIONS

    Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson's disease. This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish oil.

  • WARNINGS

    Administration of ometa-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

  • PRECAUTIONS

    General

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses 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.

    The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Safety and effectiveness in elderly populations have not been established.

  • DRUG INTERACTIONS

    WesNatal DHA Complete is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

  • 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.
  • ADVERSE REACTIONS

    Adverse reactions with iron therapy are usually transient and may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain.

  • DESCRIPTION

    WesNatal Complete tablets are clear coated, speckled light brown, oval tablets with debossed "251" on one side. WesNatal DHA Complete soft gelatin capsules are oblong, clear transparent soft gel capsules containing a pale yellow oil/liquid.

  • DIRECTIONS FOR USE

    Take one tablet and one soft gelatin capsule by mouth daily, or as prescribed by a physician. The tablet and soft gelatin capsule may be taken together or at different times of the day.

  • HOW SUPPLIED

    WesNatal DHA Complete is supplied in a 30 day unit-of-use dispensing carton containing 6 blister cards of 5 tablets and 5 soft gelatin capsules each.

    Product Code: 69367-251-30

  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

  • HEALTH CLAIM

    KEEP OUT OF REACH OF CHILDREN.

    For use on the order of a healthcare practitioner.

    Call your doctor about side effects. To report side effects, call Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Manufactured for:
    Westminster Pharmaceuticals, LLC
    Nashville, TN 37217
    Made in Canada

    500392
    Rev. 02/23

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    69367-251-30
    Rx

    WesNatal DHA
    Complete

    Prenatal Multivitamin/Multimineral
    Tablets and Omega-3 Fatty Acid
    Soft Gelatin Capsules

    30 Tablets and 30 Soft Gelatin Capsules
    (6 Unit-Dose Cards of 5 tablets and
    5 soft gelatin capsules)

    Westminster
    Pharmaceuticals

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    WESNATAL DHA COMPLETE 
    wesnatal dha complete kit
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69367-251
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69367-251-301 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 BLISTER PACK 30 
    Part 26 BLISTER PACK 30 
    Part 1 of 2
    WESNATAL DHA COMPLETE 
    wesnatal dha complete tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE3000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE200 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POTASSIUM CITRATE TRIHYDRATE (UNII: ZTT95BJ9Y0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ACACIA (UNII: 5C5403N26O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/31/2023
    Part 2 of 2
    WESNATAL DHA COMPLETE 
    wesnatal dha complete capsule, gelatin coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN TYPE B BOVINE (200 BLOOM) (UNII: A7JR5F8DLH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/31/2023
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutra-Med Packaging, Inc.022004902PACK
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