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

  • NDC Code(s): 54973-3325-1, 54973-3325-3
  • 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 14, 2017

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, oral pain

    Ferrum Phosphoricum 12X HPUS

    tooth pain, oral discomfort, swelling of gums

    Magnesia Phosphoricum 12X HPUS

    tooth pain, occasional sleeplessness

    Silicea 12X HPUS

    tooth pain at night, occcasional sleeplessness

    "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 disconfort with occasional sleeplessness.

  • WARNINGS

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

    Do not use • more than directed • if your child has 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 persist or worsens

    Keep this and all medication 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 an emergency

    contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emeregency 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 Nighttime 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

  • PRICIPAL DISPLAY PANEL - 125 TABLET CARTON

    New!

    NDC 54973-3325-1

    HOMEOPATHIC

    Natural

    Relief

    Ages

    2-12

    SINCE 1903

    Hyland's

    4Kids

    Oral Pain Relief

    NIGHTTIME

    Toothache

    Sensitive Teeth

    Swelling Gums

    Oral Disconfort

    Occasional Sleeplessness

    ACTUAL SIZE 65 MG

    125 QUICK-DISSOLVING TABLETS

    SAFE & EFFECTIVE

    Carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS ORAL PAIN RELIEF NIGHTTIME 
    arnica montana,tribasic calcium phosphate,silicon dioxide,matricaria chamomilla,ferrum phosphoricum,arabica coffee bean,magnesium phosphate, dibasic trihydrate and oyster shell calcium carbonate, crude tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3325
    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
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [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
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (Of White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3325-11 in 1 CARTON08/18/2017
    1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3325-36 g in 1 PACKET; Type 0: Not a Combination Product08/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2017
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3325) , pack(54973-3325) , label(54973-3325)