Label: B-SERENE RX- pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch

  • NDC Code(s): 69833-030-30
  • Packager: Spring Hill Therapeutics LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated January 14, 2016

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Active Ingredients
    Serving Size: 1 patch
    Amount per serving %DV
    Daily Value for adults and children four or more years of age
    *
    Daily Value (DV) not established
    Vitamin B6 (Pyridoxine Hydrochloride) 75 mg 3000%
    Vitamin B12 (Cyanocobalamin) 12 mcg 150%
    Folic Acid 1.2 mg 150%
    Ginger 500 mg *
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  • Uses

    B-Serene Rx is indicated to provide B-Vitamin supplementation, with ginger to help calm preganancy related nausea and vomiting (morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen.

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  • Warnings

    For external use only • Use only as directed • Avoid contact with eyes and mucous membranes • Do not use with heating devices or pads • Do not bandage tightly • If contact does occur with eyes rinse with cold water and call a doctor • 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 progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and any drugs, herbs and/or supplements consumption should be considered. • Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Concomitant use of ginger in pateints with heavy bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.

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  • Inactive Ingredients

    Methacrylic acid, ethylhexylacrylate, bentonite, sodium stearate.

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  • Do not use

    On wounds or damaged skin. Children under 12 years old, consult a doctor. If you are allergic to any ingredients in this product. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    Keep out of the reach of children.

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  • Directions

    Use one patch as directed or every 6-12 hours.

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  • Other Information

    Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86° F)

    See USP Controlled Room Temperature • Protect from freezing.

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  • HEALTH CLAIM

    These statements have not been approved by the FDA, This product is not intended to diagnose, treat, cure or prevent any disease.

    SPRING HILL
    THERAPEUTICS

    8270 Woodland Center Blvd. • Tampa, FL 33614
    FOR QUESTIONS CALL 813-388-8735

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  • PRINCIPAL DISPLAY PANEL - 30 Patch Bag Label

    B-SereneRx

    • Anti-Nausea Patch
    • Dietary Supplement
    • Rx prenatal vitamin with B Vitamins and Ginger
    • Formulated to ease symptoms commonly associated
      with pregnancy, including nausea and vomiting.

    30 Patches
    NDC # 69833-030-30
    Rx Only

    PRINCIPAL DISPLAY PANEL - 30 Patch Bag Label
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  • INGREDIENTS AND APPEARANCE
    B-SERENE RX 
    pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69833-030
    Route of Administration TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 75 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1200 ug
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    2-Ethylhexyl Acrylate (UNII: HR49R9S6XG)  
    Methacrylic Acid (UNII: 1CS02G8656)  
    Bentonite (UNII: A3N5ZCN45C)  
    Sodium Stearate (UNII: QU7E2XA9TG)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:69833-030-30 30 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 01/05/2015
    Labeler - Spring Hill Therapeutics LLC (079813250)
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