Label: CHAMOMILLA- matricaria chamomilla tablet

  • 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 December 7, 2022

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  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Chamomilla 6X HPUS

    occasional sleeplessness, fussiness, and irritability

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

  • Uses

    Temporarily relieves the symptoms of occasional sleeplessness, fussiness, and irritability

  • Warnings

    Do not use:  • more than directed.  • if you have a known allergy to any ingredient in this product.

    Consult a physician if symptoms persist for more than 7 days or worsen.

    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 imprinted 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 6 months of age:

    consult a licensed health care professional before using this product.

    Children 6 months to 2 years of age:

    dissolve 2 tablets under tongue every 15 minutes for 3 doses, then 2-3 times daily until

    relieved.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PURPOSE

    RELIEF OF OCCASIONAL SLEEPLESSNESS, FUSSINESS AND IRRITABILITY

  • PRINCIPAL DISPLAY PANEL - 125 TABLET BOTTLE CARTON

    New!

    NDC 54973-3347-1

    HOMEOPATHIC

    SINCE 1903

    Hyland's®

    Baby

    Natural

    Relief

    Comfort

    Chamomilla

    One Active Ingredient

    RELIEF OF

    OCCASIONAL

    SLEEPLESSNESS,

    FUSSINESS AND

    IRRITABILITY*

    No Artificial Flavors,

    Dyes or Parabens

    ACTUAL SIZE 65 MG

    125 QUICK-DISSOLVING TABLETS

    Carton

  • INGREDIENTS AND APPEARANCE
    CHAMOMILLA 
    matricaria chamomilla tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3347
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (White to Off-White) Scoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3347-11 in 1 CARTON02/02/2018
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/02/2018
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3347) , pack(54973-3347) , label(54973-3347)
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