Label: TUMMY ACHE 4KIDS- silver nitrate, asafetida, activated charcoal, matricaria recutita, cinchona officinalis bark, citrullus colocynthis fruit pulp, lycopodium clavatum spore, nutmeg, and pulsatilla vulgaris tablet

  • NDC Code(s): 54973-3196-1, 54973-3196-3
  • 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 July 29, 2019

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

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Argentum Nitricum 6X HPUSstomach pain, upset stomach due to nervousness, nausea
    Asafoetida 6X HPUSabdominal pain, inclination to vomit
    Carbo Vegetabilis 12X HPUSstomach cramps, upset stomach due to nervousness

    Chamomilla 6X HPUS

    nausea
    Cinchona Officinalis 6X HPUSstomach pressure and pain, diarrhea
    Colocynthis 6X HPUSdiarrhea, abdominal pain
    Lycopodium 30X HPUSgas
    Nux Moschata 6X HPUSstomach pressure, nausea, diarrhea
    Pulsatilla 6X HPUSupset stomach, stomach pain

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

  • Uses

    Temporarily relieves the symptoms of: • minor abdominal or stomach pain • upset stomach due to nervousness • stomach pressure or cramps • gas • nausea • diarrhe

  • Warnings

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

    Consult a physician if:

    • fever develops
    • diarrhea lasts for more than 2 days worsens
    • other 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-evident bottle cap band is broken or missing.

    The inner packaged bottle is child-resistant. 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.

  • SPL UNCLASSIFIED SECTION

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

  • Drug Facts (continued)

    Directions

    children 2 years to under 6 yearsdissolve 1 tablet under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required
    children 6 years to under 12 yearsdissolve 2 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required
    adults and children 12 years and overdissolve 3 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PURPOSE

    Temporarily relieves minor abdominal and stomach pain, upset stomach due to nervousness, stomach pressure and cramps, gas, nausea, and diarrhea.

  • PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

    NDC 54973-3196-1
    HOMEOPATHIC

    Natural
    Relief

    Ages
    2-12

    SINCE 1903
    Hyland's
    4Kids

    Tummy Ache*

    Upset Stomach
    Due to Nervousness

    Stomach Pain

    Diarrhea

    Gas

    50 QUICK-DISSOLVING TABLETS
    ACTUAL SIZE 194 MG

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    TUMMY ACHE 4KIDS 
    silver nitrate, asafetida, activated charcoal, matricaria recutita, cinchona officinalis bark, citrullus colocynthis fruit pulp, lycopodium clavatum spore, nutmeg, and pulsatilla vulgaris tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3196
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_X]
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA6 [hp_X]
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK6 [hp_X]
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3196-11 in 1 CARTON10/20/2014
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3196-34 in 1 PACKET; Type 0: Not a Combination Product10/20/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/20/2014
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3196) , pack(54973-3196)