The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Diarrheacalm (NDC 0220-9110). 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, indications & usage, otc - purpose, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each tablet)
Arsenicum album 9C HPUS (0.83 mg) (contains less than 10 -18 mg arsenic)
Cinchona officinalis 5C HPUS (0.83 mg)
Podophyllum peltatum 9C HPUS (0.83 mg)
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*
temporarily relieves symptoms of diarrhea such as:
▪ traveler’s diarrhea ▪ intestinal pain ▪ bloating ▪ gas ▪ nausea ▪ vomiting
Purpose*
Arsenicum album 9C HPUS (0.83 mg)………. Relieves diarrhea with nausea, vomiting, and weakness
Cinchona officinalis 5C HPUS (0.83 mg)……..………Relieves diarrhea with gas and bloating
Podophyllum peltatum 9C HPUS (0.83 mg)……Relieves diarrhea with intestinal rumbling and pain
Ask a doctor before use if you have
▪ fever ▪ bloody or black stool ▪ mucus in your stool
Stop use and ask a doctor if symptoms persist for more than 2 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.
Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
▪ Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 4 to 6 hours, up to 2 days maximum. Discontinue use as soon as symptoms disappear.
▪ Children under 6 years of age: Ask a doctor.
croscarmellose sodium, lactose, magnesium stearate
Other information ▪ do not use if glued carton end flaps are open or if the blister seal is broken ▪ store below 86°F (30°C)
DIARRHEA RELIEF*
Intestinal Pain ▪ Nausea ▪ Taveler's Diarrhea*
No Known Drug Interactions
60 Meltaway Tablets
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
*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.
