The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Gascalm (NDC 0220-9136). 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 otc - active ingredient, otc - purpose, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each tablet)
Carbo vegetabilis 6C HPUS (0.63 mg)
Lycopodium clavatum 6C HPUS (0.63 mg)
Nux moschata 6C HPUS (0.63 mg)
Raphanus sativus 6C HPUS (0.63 mg)
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Carbo vegetabilis 6C HPUS ...Relieves stomach bloating with gas
Lycopodium clavatum 6C HPUS ... Relieves bloated lower abdomen
Nux moschata 6C HPUS... Relieves abdominal bloating accompanied by constipation
Raphanus sativus 6C HPUS... Relieves abdominal pain and bloating with difficulty passing gas
Uses*
temporarily relieves bloating, pressure, discomfort, and pain commonly referred to as gas
Stop use and ask a doctor if symptoms persist continuously for more than 7 days or worsen.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
croscarmellose sodium, lactose, magnesium stearate
BoironUSA.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
do not use if glued carton and flaps are open or if the blister seal is broken
store below 86°F (30° C)
Plant-Powered Relief
No Known Drug Interactions
60 Meltaway Tablets, unflavored
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C, K, CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
