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

Tummy Ache 4Kids by

Drug Labeling and Warnings

Tummy Ache 4Kids by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

• 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.

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 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

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

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)