The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Belly Calm (NDC 68703-383). 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 hpus active ingredients, uses*, warnings, directions, other safety information, inactive ingredients, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HPUS Active Ingredients: Equal volumes of each ingredient in a 6C potency: Arg nit, Asafoetida, Carbo veg, Chamomilla, Lycopodium, Mag phos, Nat phos, Nux mosch, Zingiber.
The letters HPUS indicate that the components in this product are offically momographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic relief from upset stomach, diarrhea, gas & bloating, and nervous stomach in children.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use.
Keep this and all medication out of reach of children.
In case of overdose, get medical help or contact Poison Control Center right away.
Directions: Chew or dissolve tablets in the mouth. For children 2-6 years: 1 tablet, 7-12 years: 2 tablets, 13+ years: 3 tablets. Dose every 15 minutes up to 6 doses, then every 4 hours until relieved.
Contains no artificial flavors or colorants. No gluten added. Lactose-free.
Inactive ingredients: Magnesium Stearate, Maltodextin, Sucrose.
Keep this and all medication out of reach of children.
If pregnant or breast feeding, ask a health professional before use.
Temporarily relieves discomfort caused by nervous tummy, upset stomach, diarrhea, gas & bloating.*
* Please review the disclaimer below.
