FDA Label for Diarrheacalm
View Indications, Usage & Precautions
Diarrheacalm Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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.
Indications & Usage
Uses*
temporarily relieves symptoms of diarrhea such as:
▪ traveler’s diarrhea ▪ intestinal pain ▪ bloating ▪ gas ▪ nausea ▪ vomiting
Otc - Purpose
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
Otc - Ask Doctor
Ask a doctor before use if you have
▪ fever ▪ bloody or black stool ▪ mucus in your stool
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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.
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
Questions or comments?
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Other
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.
Package Label.Principal Display Panel
* Please review the disclaimer below.
