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BABY INFANT EARACHE DROPS (Hyland's)

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Dosage Form Package Information Links
LIQUID 10 mL in 1 BOTTLE, DROPPER (54973-7516-3) Label Information

Complete BABY INFANT EARACHE DROPS Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Belladonna 30C HPUS

    (less than 0.0000000000001 % Alkaloids, calculated)

    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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States


  • PURPOSE

    Temporarily relieves the symptoms of fever, pain, throbbing, irritability, and occasional sleeplessness associated with earaches in children after diagnosis by a physician. Relieves common pain and itching of swimmer's ear.


  • Uses

    Temporarily relieves the symptoms of fever, pain, throbbing, irritability, and occasional sleeplessness associated with earaches in children after diagnosis by a physician. Relieves common pain and itching of swimmer's ear.


  • Warnings

    Keep away from eyes. Do not take by mouth.

    Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal. Consult a physician if:

    • Symptoms persist for more than 48 hours
    • Discharge from ear is present

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

    Do not use if tamper band is broken or missing.

    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 under 3 years of age: Tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application, or gently place cotton in ear to keep drops in.


  • Inactive ingredients

    Citric Acid,Glycerine, Purified Water, Sodium Benzoate.


  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    NDC 54973-7516-3
    HOMEOPATHIC

    Ages

    6 months+

    SINCE 1903
    Hyland's ®
    Baby

    Natural
    Relief

    Infant
    Earache Drops

    FAST, SOOTHING

    RELIEF OF EAR PAIN
    AND IRRITABILITY*

    ‣ No Antibiotics, Artificial Flavors, Dyes or Parabens

    0.33 FL.OZ. (10mL)

    carton


  • INGREDIENTS AND APPEARANCE
    BABY INFANT EARACHE DROPS 
    belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-7516
    Route of Administration AURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF 30 [hp_C]  in 1 mL
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 30 [hp_C]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_C]  in 1 mL
    ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD) ANEMONE PATENS 30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-7516-3 1 in 1 CARTON 03/16/2004
    1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/16/2004
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-7516) , pack(54973-7516)
    Establishment
    Name Address ID/FEI Business Operations
    Lifetech Resources 622559110 manufacture(54973-7516) , pack(54973-7516)