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.
Updated July 29, 2019
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Active ingredients Purpose Argentum Nitricum 6X HPUS stomach pain, upset stomach due to nervousness, nausea Asafoetida 6X HPUS abdominal pain, inclination to vomit Carbo Vegetabilis 12X HPUS stomach cramps, upset stomach due to nervousness
Chamomilla 6X HPUS
nausea Cinchona Officinalis 6X HPUS stomach pressure and pain, diarrhea Colocynthis 6X HPUS diarrhea, abdominal pain Lycopodium 30X HPUS gas Nux Moschata 6X HPUS stomach pressure, nausea, diarrhea Pulsatilla 6X HPUS upset stomach, stomach pain
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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.
- SPL UNCLASSIFIED SECTION
Drug Facts (continued)
children 2 years to under 6 years dissolve 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 years dissolve 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 over dissolve 3 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3196 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 6 [hp_X] ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 6 [hp_X] ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X] CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 6 [hp_X] CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_X] NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 6 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3196-1 1 in 1 CARTON 10/20/2014 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3196-3 4 in 1 PACKET; Type 0: Not a Combination Product 10/20/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/20/2014 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3196) , pack(54973-3196)