DiarrheaCalm

Manufacturer
Boiron | Boiron, Inc.
Effective date
2025-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:32:31

Label at a glance#

ProductDiarrheaCalm
Active ingredientPODOPHYLLUM, CINCHONA OFFICINALIS BARK, ARSENIC TRIOXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each pellet)

Arsenicum album 9C HPUS (0.15 mg)(contains less than 10 -18 mg arsenic)

Cinchona officinalis 5C HPUS (0.15 mg)

Podophyllum peltatum 9C HPUS (0.15 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Arsenicum album 9C HPUS (0.15 mg)………. Relieves diarrhea with nausea, vomiting, and weakness

Cinchona officinalis 5C HPUS (0.15 mg)……..………………………Relieves diarrhea with gas and bloating

Podophyllum peltatum 9C HPUS (0.15 mg)……Relieves diarrhea with intestinal rumbling and pain

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves symptoms of diarrhea such as: ▪ traveler’s diarrhea ▪ intestinal pain ▪ bloating ▪ gas ▪ nausea ▪ vomiting

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have ▪ fever ▪ bloody or black stool ▪ mucus in your stool

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 5 pellets under the tongue 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 SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

1-800-264-7661

SPL UNCLASSIFIED SECTION

Other information ▪ do not use if glued carton end flaps are open or if pellet dispenser seal is broken ▪ contains 0.25 g of sugar per dose

Do not use if pellet dispenser seal is broken.

MULTI-SYMPTOM DIARRHEA RELIEF*

Bloating, Nausea, Vomiting*

2 Portable tubes

Approx. 80 Pellets each, 3.8 g (0.13oz)

Total 160 pellets

Turn tube upside down

Twist until 5 pellets are dispensed

Turn tube upside down & twist cap

Distributed by

Boiron Inc.

Made in France

*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

labellabel

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9109-41DiarrheaCalm2 in 1 TUBEPELLET21
0220-9109-42DiarrheaCalm2 in 1 BOXPELLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9109DIARRHEACALM (ARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, PODOPHYLLUM) PELLET [BOIRON]1Current NDC, 2 package rows20250315_30293788-e30b-d650-e063-6394a90a9517.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-91090220-9109-41, 0220-9109-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiarrheaCalmARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, PODOPHYLLUMBoiron30293788-e30b-d650-e063-6394a90a95172025-03-12Exact identifier
ndc (package): 0220-9109-41
ndc (package): 0220-9109-42
ndc (product): 0220-9109
ndc11 (package): 00220910942
ndc11 (package): 00220910941
spl id: 30293788-e30c-d650-e063-6394a90a9517
spl set id: 30293788-e30b-d650-e063-6394a90a9517

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.