Label: HEADACHE EASE- aur met, belladonna, bryonia, gelseisum, ignatia, kali phos, nat mur, nux vom, sepia 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 December 25, 2023

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  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal volumes of each ingredient in a 12C potency: Aur met, Belladonna, Bryonia, Gelsemium, Ignatia, Kali phos, Nat mur, Nux vom, Sepia.

  • Uses*

    Uses*: Homeopathic relief of common headache symptoms.

  • Warnings

    Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center.

  • Directions

    Directions: Chew or dissolve tablets int he mouth. For Adults and Children 12+: Take 2 tablets every 15-20 minutes up to 4 doses, then every 4 hours until symptoms subside.

  • OTHER SAFETY INFORMATION

    Contains no artificial flavors or colorants. No gluten added. Lactose-free.

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

  • Inactive Ingredients

    Inactive Ingredients: Magnesium Stearate, Maltodextrin, Sucrose.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Temporarily relieves common headache symptoms*

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • PRINCIPAL DISPLAY PANEL

    Headache Ease label

  • INGREDIENTS AND APPEARANCE
    HEADACHE EASE 
    aur met, belladonna, bryonia, gelseisum, ignatia, kali phos, nat mur, nux vom, sepia tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-374
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_C]  in 180 
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC12 [hp_C]  in 180 
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_C]  in 180 
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_C]  in 180 
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_C]  in 180 
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_C]  in 180 
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_C]  in 180 
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_C]  in 180 
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_C]  in 180 
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize3mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-374-80180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/20/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2021
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(68703-374)
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