Label: IGNATIA AMARA- ignatius bean granule

  • 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 October 2, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    IGNATIA AMARA (Ignatius bean) 12CH GR

    IGNATIA AMARA (Ignatius bean) 15CH GR

    IGNATIA AMARA (Ignatius bean) 200CH GR

    IGNATIA AMARA (Ignatius bean) 200K GR

    IGNATIA AMARA (Ignatius bean) 30CH GR

    IGNATIA AMARA (Ignatius bean) 30K GR

    IGNATIA AMARA (Ignatius bean) 4CH GR

    IGNATIA AMARA (Ignatius bean) 5CH GR

    IGNATIA AMARA (Ignatius bean) 7CH GR

    IGNATIA AMARA (Ignatius bean) 9CH GR

    IGNATIA AMARA (Ignatius bean) CMK GR

    IGNATIA AMARA (Ignatius bean) MK GR

    IGNATIA AMARA (Ignatius bean) XMK GR

  • PURPOSE

    Indications

    For the temporary relief of nervousness and irritation

  • WARNINGS

    Warning

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

    Keep out of reach of children.

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Lactose,

    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    For the temporary relief of nervousness and irritation

    Directions

    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

    Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-8200

    UNDA

    Do not use if label perforation is broken

    Homeopathic Remedy

    NDC : 62106-8200-4

    IGNATIA AMARA

    Ignatius bean

    140 granules

    Indications

    For the temporary relief of nervousness and irritation

  • INGREDIENTS AND APPEARANCE
    IGNATIA AMARA 
    ignatius bean granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-8200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-8200-410 in 1 CARTON01/29/201507/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/29/201507/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-8200)
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