Label: HEADACHE SOOTHE- chamomilla, cinchona, kali phos, mag phos, nux vom tincture

  • 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 April 11, 2013

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

  • PURPOSE

    Relieves headache and nervous tension

  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of: Chamomilla 12C HPUS, Cinchona 12C HPUS, Kali phos 6X HPUS, Mag phos 12X HPUS, Nux vom 12C HPUS

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for headache relief

  • WARNINGS

    Warnings: If symptoms persist or worsen, consult a health care professional

  • PREGNANCY OR BREAST FEEDING

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

  • 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 Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions: Adults and Children 13+: Mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 20-30 minutes as needed until symptoms subside. If preferred, drops may betaken directly into the mouth. Children under 13: Reduce serving size to 0.25 mL

  • INACTIVE INGREDIENT

    Inactive Ingredients: USP Purified water, grain alcohol (20% by volume), Lactose

  • 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 expert 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 animal products, glutenm artificial flavors, preservatives or colorants. Suitable for vegetarians and safe for all ages

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    HEADACHE SOOTHE 
    chamomilla, cinchona, kali phos, mag phos, nux vom tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [hp_C]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK12 [hp_C]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-085-5959 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc137752817manufacture(68703-085) , api manufacture(68703-085)