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

  • NDC Code(s): 54973-3324-1, 54973-3324-4
  • 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, swelling and occasional sleeplessness

  • Drug Facts

    Active ingredients

    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

    Magnesia Phosphorica 12X HPUS

    oral pain, occasional sleeplessness

    Silicea 12X HPUS

    oral pain at night, occasional sleeplessness

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

  • Uses

    ■ Temporarily relieves symptoms of oral pain or discomfort in children at night, including:

    ■ gum sensitivity ■ swelling or soreness of gums

    ■ irritability  ■ occasional sleeplessness

  • 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.

    Keep this and all medications out of the reach of children.

  • Directions

    ■ Use as directed

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

  • PACKAGE LABEL

    Hyland's

    NATURALS

    baby

    Oral Pain

    Relief

    NO BENZOCAINE,
    DYES or PARABENS

    Sleeplessness
    Teething Pain
    Oral Discomfort
    Irritability
    Swelling

    0+ MONTHS

    125

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    1

  • INGREDIENTS AND APPEARANCE
    BABY NIGHTTIME ORAL PAIN RELIEF 
    arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3324
    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
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [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
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [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:54973-3324-11 in 1 CARTON08/17/2017
    11 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3324-46 g in 1 PACKET; Type 0: Not a Combination Product08/17/201712/27/2021
    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(54973-3324) , pack(54973-3324) , label(54973-3324)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3324) , pack(54973-3324) , label(54973-3324)