Active Ingredients
Arsenicum album 6X
Ipecacuanha (Ipecac) 6X
Mercurius corrosivus 6X
Podophyllum peltatum (Mayapple) 6X
Kids Upset Tummy Relief
FDA Label NDC 59262-607
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Kids Upset Tummy Relief (NDC 59262-607). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses*, warnings, keep out of reach of children., stop use and ask a doctor if:, directions adults and children ages 2 and older:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
diarrhea, nausea, stomach cramps, bloating
nausea, vomiting
stomach pain
bloating, nausea, cramps
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• Nausea
• Stomach Pain
• Diarrhea
• Bloating
• Cramps
Warnings
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Do not exceed recommended dosage.
• Not intended for children under 2.
• Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Stop Use And Ask A Doctor If:
symptoms worsen or persist for more than 72 hours
Directions Adults And Children Ages 2 And Older:
Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredients
Lactose, Magnesium stearate
Questions?
Reach our representatives at 1-800-240-9780 or [email protected]. www.SimilasanUSA.com
*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Principal Display Panel
NDC 59262-607-30
Similasan
Kids Upset
Tummy
Relief
Mayapple Actives
60 Dissolvable Tablets
Principal Display Panelndc 59262-607-30similasankids Upsettummyreliefmayapple Actives60 Dissolvable Tablets (Kids Upset Tummy Relief 01)
* Please review the disclaimer below.
