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

  • NDC Code(s): 54973-3315-1, 54973-3315-3, 54973-3315-7
  • 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 27, 2021

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

  • PURPOSE

    Relieves oral discomfort, pain, irritability and swelling

  • Drug Facts

    Active ingredients

    Purpose

    Arnica Montana 30X HPUS

    sore, sensitive or swelling gums

    Calcarea Carbonica 12X HPUS

    sore, sensitive or swelling gums

    Calcarea Phosphorica 12X HPUS

    sensitive, swelling gums, oral pain

    Chamomilla 12X HPUS

    sore, sensitive or swelling gums

    Coffea Cruda 6X HPUS

    oral pain, irritability

    Ferrum Phosphoricum 12X HPUS

    oral discomfort, swelling gums

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

  • Uses

    ■Temporarily relieves symptoms of oral pain or discomfort in children, including:
    ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability

  • Warnings

    Stop use and ask a doctor if

    ■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or
    develops. ■ irritation, pain or redness persists or worsens.

    Keep out of reach of children

  • Directions

    ■ Use as directed.

    Children under 6 monthsAt onset of symptoms, dissolve 2 tablets on tongue
    every hour up to 4 hours. If symptoms persist,
    2 tablets every 4 hours until relieved.
    Children 6 months
    to under 3 years
    At onset of symptoms, dissolve 3 tablets on tongue
    every hour up to 4 hours. If symptoms persist,
    3 tablets every 4 hours until relieved.

  • Inactive ingredients

    Acacia Gum, Lactose

  • Questions?

    www.hylands.com or (800) 624-9659

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL

    Hyland's

    NATURALS

    •baby•

    Oral Pain

    Relief*

    DAYTIME

    NO BENZOCAINE,
    DYES or PARABENS

    Teething Pain
    Oral Discomfort
    Irritability
    Swelling

    0+ MONTHS

    125 QUICK-DISSOLVING

    TABLETS

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY ORAL PAIN RELIEF 
    oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3315
    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
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [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
    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
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3315-11 in 1 CARTON08/17/2017
    1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3315-36 g in 1 PACKET; Type 0: Not a Combination Product08/17/201712/27/2021
    3NDC:54973-3315-71 in 1 CARTON08/17/2017
    380 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/17/2017
    Labeler - HYLAND'S (028570695)
    Registrant - STANDARD HOMEOPATHIC COMPANY (Hyland's) (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    STANDARD HOMEOPATHIC COMPANY008316655manufacture(54973-3315) , pack(54973-3315) , label(54973-3315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3315) , pack(54973-3315) , label(54973-3315)