Label: HEADACHE SOOTHE- china , nux vom, chamomilla, kali phos , mag phos 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 July 29, 2010

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  • PURPOSE

    Relieves headaches and nervous tension

  • INDICATIONS & USAGE

    Indications: Homeopathic remedy for headache relief.

  • DOSAGE & ADMINISTRATION

    Dosage: Mix 10 drops in ¼ cup water and sip slowly. Repeat every 20-30 minutes as needed until symptoms subside. If preferred, drops may be taken directly into the mouth. Children under 12: Reduce dosage to 5 drops.

  • GENERAL PRECAUTIONS

    Caution: Consult your doctor if symptoms persist or worsen. Keep this and all medicines out of reach of children.

  • ACTIVE INGREDIENT

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

  • INACTIVE INGREDIENT

    Citricidal Extract (inactive ingredient).

  • PREGNANCY

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

  • WARNINGS

    Contains no animal products, gluten, artificial flavors, preservatives, colorants or alcohol. Suitable for vegetarians and safe for all ages.

  • INFORMATION FOR PATIENTS

    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

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INGREDIENTS AND APPEARANCE
    HEADACHE SOOTHE 
    china , nux vom, chamomilla, kali phos , mag phos tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AILANTHUS ALTISSIMA FLOWERING TWIG (UNII: 8P29O5P7XU) (AILANTHUS ALTISSIMA FLOWERING TWIG - UNII:8P29O5P7XU) AILANTHUS ALTISSIMA FLOWERING TWIG12 [hp_C]  in 40 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_C]  in 40 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE12 [hp_C]  in 40 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 40 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 49.486 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68647-171-1050000 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2010
    Labeler - Feelgood Health (538418296)
    Establishment
    NameAddressID/FEIBusiness Operations
    W. Last567284153manufacture
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