4 KIDS EARACHE RELIEF (MATRICARIA CHAMOMILLA,FERRIC PHOSPHATE,SULFUR,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE AND ANEMONE PULSATILLA) TABLET [HYLAND'S INC.]

4 KIDS EARACHE RELIEF (MATRICARIA CHAMOMILLA,FERRIC PHOSPHATE,SULFUR,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE AND ANEMONE PULSATILLA) TABLET [HYLAND'S INC.]
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NDC 54973-3393-1
Set ID 7a7facbe-f245-d991-e053-2a91aa0aa26f
Category HUMAN OTC DRUG LABEL
Packager Hyland's Inc.
Generic Name
Product Class
Product Number
Application Number
  • Drug Facts

    Active ingredients

    Calcarea Carbonica 30C HPUS

    Chamomilla 30C HPUS

    Ferrum Phosphoricum 30C HPUS

    Lycopodium 30C HPUS

    Pulsatilla 30C HPUS

    Sulphur 30C HPUS

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

    Pharmacopœia of the United States.

    Purpose

    Calcarea Carbonica 30C HPUS.....................................................throbbing ear pain

    Chamomilla 30C HPUS ...............................occasional sleeplessness and irritability

    Ferrum Phosphoricum 30C HPUS...........................................................minor fever

    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

  • 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.

    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 101ºF).

    Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

    Do not use if imprinted tamper-evident bottle cap band is broken or missing.

    The inner packaged bottle is child resistant.

    In case of emergency

    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

    Children 2 years

    to under 6 years

    Dissolve 2 tablets under tongue every 8 hours

    until relieved for up to 48 hours.

    Children 6 years

    to under 12 years

    Dissolve 3 tablets under tongue every 8 hours

    until relieved for up to 48 hours.

    Adults and children

    12 years and over

    Dissolve 4 tablets under tongue every 8 hours

    until relieved for up to 48 hours.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • Principal Display Panel - 40 Tablets Bottle Carton

    New!

    NDC 54973-3393-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4 Kids

    Earache Relief*

    Ear Pain

    Fever

    Irritability

    40 QUICK-DISSOLVING TABLETS

    ACTUAL SIZE 194 MG

    carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS EARACHE RELIEF 
    matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3393
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_C]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (to Off-White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3393-11 in 1 CARTON12/01/2018
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2018
    Labeler - Hyland's Inc. (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3393) , pack(54973-3393) , label(54973-3393)

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