Label: BIRTH-HEAL- angelica, arnica, mag phos, passiflora, silicea tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 29, 2012

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  • PURPOSE

    Reduces swelling and bruising after childbirth - with Arnica
  • ACTIVE INGREDIENT

    Active Ingredients: Each serving contains equal parts of: Angelica 6X HPUS, Arnica 6C HPUS, Mag phos 8X HPUS, Passiflora 3X HPUS, Silicea 8X HPUS.

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for common post-birth swelling, pain and soreness.

  • WARNINGS

    Warnings: If symptoms persist or worsen, consult a healthcare professional.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Adults: On first day, take 2 tablets every 2 hours after childbirth. Thereafter, take 4 tablets 3 times per day for 3 weeks.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acacia gum, lactose, magnesium stearate, corn starch, sucrose.
  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

    Distributed by
    Native Remedies, LLC
    6531 Park of Commerce Blvd.
    Suite 160
    Boca Raton, FL 33487
    Phone: +1.877.289.1235
    International: +1.561.999.8857

    Contains no artificial flavors or artificial colors. No gluten added.

  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact.

  • PRINCIPAL DISPLAY PANEL

    Bottle label

  • INGREDIENTS AND APPEARANCE
    BIRTH-HEAL 
    angelica, arnica, mag phos, passiflora, silicea tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT6 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White lactose tablets) Scoreno score
    ShapeROUND (Round white lactose tablets) Size5mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-033-80180 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2012
    Labeler - Native Remedies, LLC (192014186)
    Registrant - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350api manufacture(68703-033) , manufacture(68703-033)
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