EARACHE RELIEF (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)) TABLET [THE MAGNI COMPANY]

EARACHE RELIEF (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)) TABLET [THE MAGNI COMPANY]
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NDC 43689-0020-1, 43689-0020-2
Set ID 3f62001a-27b5-43cb-8006-110943facf87
Category HUMAN OTC DRUG LABEL
Packager The Magni Company
Generic Name
Product Class
Product Number
Application Number
  • 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 RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [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 (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR12 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [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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