Label: EARACHE RELIEF (belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla- vulgaris 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 January 10, 2022

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  • ACTIVE INGREDIENTS:

    Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.

  • USES:

    For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

  • WARNINGS:

    • 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.

    • Stop use and ask a doctor if you experience worsening symptoms or if symptoms last longer than 7 days.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • OTHER INFORMATION:

    • Store tightly closed in a cool, dry place (59° - 86°F)

    • Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

    • The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United
       States

    • These statements are supported by the traditional homeopathic principles

  • DIRECTIONS:

    Adults and children 12 years and above:  dissolve 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician.

    Children under 12 years, consult a physician.

  • INDICATIONS:

    For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

  • INACTIVE INGREDIENTS:

    Lactose, Magnesium Stearate, Microcrystalline Cellulose

  • QUESTIONS:

    Dist. by: The Magni Group, Inc. McKinney, TX 75071 USA

    www.magnilife.com                               1-800-645-9199

  • PACKAGE LABEL DISPLAY:

    MAGNILIFE Homeopathic

    NDC 43689-0020-1

    EARACHE RELIEF

    Targets ear pain
    for fast relief

    Soothes ear pain and
    discomfort due to:
    √ Allergy
    √ Cold & Flu
    √ Congestion
    √Swimmer's Ear

    90 Dissolving Tablets

    Earache Relief lbl

    Earache Relief ctn

  • INGREDIENTS AND APPEARANCE
    EARACHE RELIEF 
    belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla (vulgaris) tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE12 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]
    PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE12 [hp_X]
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Convex) Size6mm
    FlavorImprint Code ML
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0020-21 in 1 PACKAGE08/24/2016
    1NDC:43689-0020-190 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2016
    Labeler - The Magni Company (113501902)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43689-0020) , api manufacture(43689-0020) , label(43689-0020) , pack(43689-0020)
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