EARACHE (MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR, PULSATILLA VULGARIS AND LYCOPODIUM CLAVATUM SPORE) TABLET [HYLAND'S]

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  • EARACHE (MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR, PULSATILLA VULGARIS AND LYCOPODIUM CLAVATUM SPORE) TABLET [HYLAND'S]

EARACHE (MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR, PULSATILLA VULGARIS AND LYCOPODIUM CLAVATUM SPORE) TABLET [HYLAND'S]
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NDC 54973-3169-1
Set ID 56bdf20b-0a8a-4532-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts

    Active ingredients

    Purpose

    Belladonna 30C HPUS

    minor fever

    (less than 0.000000000001% Alkaloids, calculated)

    Calcarea Carbonica 30C HPUS

    throbbing ear pain

    Chamomilla 30C HPUS

    occasional sleeplessness and irritability

    Lycopodium 30C HPUS

    ear pain

    Pulsatilla 30C HPUS

    ear itching, pain worse at night,minor fever

    Sulphur 30C HPUS

    ear pain with burning,minor fever

    “HPUS” indicates that the active ingredients are in the official

    Homeopathic Pharmacopoeia of the United States.

    minor fever

    throbbing ear pain

    occasional sleeplessness and irritability

    ear pain

    ear itching, pain worse at night, minor fever

    ear pain with burning, minor fever

  • Uses

    • Temporarily relieves the symptoms of:
    • minor fever 
    • ear pain or throbbing
    • occasional sleeplessness or irritability associated with earaches after diagnosis by a physician
  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Do not use more than directed.

    Consult a physician if:

    • symptoms persist for more than 48 hours or worsen.
    • discharge from ear is present. 
    • symptoms are accompanied by a high fever (over 101°F).

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or Poison

    Control Center immediately. Hyland’s may also be contacted for emergency information

    about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults and children

    12 years and over

    Dissolve 2-3 tablets under tongue every 8 hours

    until relieved for up to 48 hours.

  • Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident

    bottle cap band is broken or missing.

    • The inner packaged bottle is child-resistant.
  • INACTIVE INGREDIENT

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

    NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Principal Display Panel - 40 Tablet Carton

    NDC 54973-3169-1

    HOMEOPATHIC

    Natural

    Relief

    SINCE 1903

    Hyland's®

    EARACHE

    TABLETS

    RELIEVES EAR PAIN FAST*

    CALMS & SOOTHES

    EARACHES DUE TO:

    • COLD & FLU
    • ALLERGY
    • MINOR FEVER

    40 QUICK-DISSOLVING TABLETS

    ACTUAL SIZE 194 MG

    *SEE NOTE ON BACK PANEL

    BELOW DRUG FACTS

    CARTON

  • INGREDIENTS AND APPEARANCE
    EARACHE 
    matricaria chamomilla, atropa belladonna, oyster shell calcium carbonate, crude, sulfur, pulsatilla vulgaris and lycopodium clavatum spore tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3169
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]  in 1 g
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 g
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 g
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 g
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_C]  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (Off-White) Scoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3169-11 in 1 CARTON04/15/2013
    140 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/15/2013
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3169) , pack(54973-3169) , label(54973-3169)
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