EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]

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  • EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]

EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]
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NDC 54973-3172-1, 54973-3172-2
Set ID 9b18453e-e338-4b8e-9856-85aca8c46ee1
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts

    Active ingredients

    Belladonna 30C HPUS

    (less than 0.000000000001% Alkaloids, calculated)

    Calcarea Carbonica 30C HPUS

    Chamomilla 30C HPUS

    Lycopodium 30C HPUS

    Pulsatilla 30C HPUS

    Sulphur 30C HPUS

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

    Purpose

    minor fever

    throbbing ear pain

    occasional sleeplessness and irritability

    ear pain

    ear itching,pain worse at night

    ear pain with burning

  • Uses

    Temporarily relieves the symptoms of: 

    • minor fever 
    • ear pain or throbbing 
    • irritability or occasional sleeplessness associated with earaches after diagnosis by a physician 
    • common pain or itching of "swimmer’s ear"
  • 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.

    Adults and 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

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT

    ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    NDC 54973-3172-1
    HOMEOPATHIC

    Natural
    Relief

    SINCE 1903
    Hyland's®

    EARACHE
    DROPS

    RELIEVES EAR

    PAIN FAST*

    CALMS & SOOTHES
    EARACHES DUE TO:

    • COLD & FLU
    • ALLERGY
    • MINOR FEVER

    0.33 FL. OZ.
    (10 mL)

    *SEE NOTE ON SIDE

    PANEL BELOW

    DRUG FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    EARACHE DROPS 
    belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3172
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF30 [hp_C]  in 1 mL
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE30 [hp_C]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    ANEMONE PATENS WHOLE (UNII: 4M1169RWJD) (ANEMONE PATENS WHOLE - UNII:4M1169RWJD) ANEMONE PATENS WHOLE30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3172-11 in 1 CARTON06/17/2004
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:54973-3172-21 in 1 CARTON06/17/2004
    212 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/17/2004
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3172) , pack(54973-3172)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources081239587manufacture(54973-3172) , pack(54973-3172)
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