Label: 4 KIDS EARACHE RELIEF- atropa belladonna,oyster shell calcium carbonate, crude,lycopodium clavatum spore,anemone pulsatilla,sulfur and matricaria chamomilla liquid

  • 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 November 22, 2022

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  • Purpose

    Relieves earache due to swimmer’s ear, cold, flu & allergy

  • Drug Facts

    Active ingredients

    Purpose

    Belladonna 30C HPUS

    (less than 0.000000000001% Alkaloids, calculated)

    minor fever

    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

    Sulphur 30C HPUS

    ear pain with burning

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

    itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

  • Warnings

    Keep away from eyes. Do not take by mouth.

    Earache drops are only to be used in ears.

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

    Do not use if you have ear tubes, damaged ear drums or after ear surgery.

    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).

  • Drug Facts (continued)

    Keep this and all medications out of the reach of children. If swallowed, 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

    ■ Shake well before using.

    Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

  • Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

    ■ Store at room temperature.

    ■ Do not refrigerate.

  • Inactive ingredients

    Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

  • Questions or comments?

    (800) 624-9659

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Principal Display Panel

    HOMEOPATHIC

    NDC 54973-3392-1

    2-12

    YEARS

    NEW

    LOOK

    4 KIDS

    SINCE 1903

    Hyland's

    Earache

    Relief*

    Relieves earache

    due to swimmer’s ear,

    cold, flu & allergy

    NO DYES or PARABENS

    NO NUMBING EFFECT

    NATURAL

    RELIEF*

    0.33 FL. OZ. (10 mL)

    *SEE NOTE ON SIDE

    PANEL BELOW DRUG FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS EARACHE RELIEF 
    atropa belladonna,oyster shell calcium carbonate, crude,lycopodium clavatum spore,anemone pulsatilla,sulfur and matricaria chamomilla liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3392
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3392-11 in 1 CARTON03/01/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2019
    Labeler - Hyland’s (008316655)
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