Label: 4 KIDS ORAL PAIN RELIEF- oyster shell calcium carbonate, crude, arabica coffee bean, arnica montana, tribasic calcium phosphate, ferrum phosphoricum and matricaria chamomilla tablet

  • NDC Code(s): 54973-3316-1, 54973-3316-3
  • Packager: Hyland's
  • 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 16, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredients

    Purpose

    Arnica Montana 30X HPUS

    tooth pain, sensitive or swelling gums

    Calcarea Carbonica 12X HPUS

    tooth pain, sensitive gums or teeth

    Calcarea Phosphorica 12X HPUS

    sensitive gums or teeth, oral pain

    Chamomilla 12X HPUS

    tooth pain, sensitive gums or teeth

    Coffea Cruda 6X HPUS

    tooth pain, irritability

    Ferrum Phosphoricum 12X HPUS

    tooth pain, oral discomfort, swelling of gums

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

    Pharmacopœia of the United States.

  • Uses

    Temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.

  • WARNINGS

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

    Do not use • more than directed • if your child has a known allergy to any ingredient in this product.

    Consult a physician if: • symptoms persist for more than 72 hours or worsen • swelling increases, rash or fever develops

    • irritation, pain or redness persists or worsens.

    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 2 years to under 6 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

    Children 6 years to under 12 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

    Adults and Children 12 years and over: dissolve 4 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

    Hyland’s Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.

  • INACTIVE INGREDIENT

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PURPOSE

    Oral Pain Relief

  • PRINCIPAL DISPLAY PANEL - 125 TABLET CARTON

    New!

    NDC 54973-3316-1

    HOMEOPATHIC

    Ages

    2-12

    Natural

    Relief

    SINCE 1903

    Hyland's®

    4 Kids

    Oral Pain Relief

    Toothache

    Sensitive Teeth

    Swelling Gums

    Oral Disconfort

    ACTUAL SIZE 65 MG

    125 QUICK-DISSOLVING

    TABLETS

    SAFE &

    EFFECTIVE

    Carton Art

  • INGREDIENTS AND APPEARANCE
    4 KIDS ORAL PAIN RELIEF 
    oyster shell calcium carbonate, crude, arabica coffee bean, arnica montana, tribasic calcium phosphate, ferrum phosphoricum and matricaria chamomilla tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3316
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 g
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1 g
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 g
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3316-11 in 1 CARTON08/18/2017
    1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3316-36 g in 1 PACKET; Type 0: Not a Combination Product08/18/201712/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2017
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standar Homeopathic Company008316655manufacture(54973-3316) , pack(54973-3316) , label(54973-3316)