Diarrheacalm Tablets

Diarrheacalm Tablets
SPL v1
SPL
SPL Set ID 302786a1-c6a2-f7ea-e063-6394a90a327b
Route
ORAL
Published
Effective Date 2025-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cinchona Officinalis Bark (5 [hp_C]) Podophyllum (9 [hp_C]) Arsenic Cation (3+)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-03-12

Description

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.


Medication Information

Indications and Usage

Uses*

temporarily relieves symptoms of diarrhea such as:

▪ traveler’s diarrhea ▪ intestinal pain ▪ bloating ▪ gas ▪ nausea ▪ vomiting

Dosage and 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.

Description

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.

Section 42229-5

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.

Section 50565-1

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

Section 50566-9

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

Section 50569-3

Ask a doctor before use if you have

▪ fever ▪ bloody or black stool ▪ mucus in your stool

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

Questions or comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Section 53414-9

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

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves symptoms of diarrhea such as:

▪ traveler’s diarrhea ▪ intestinal pain ▪ bloating ▪ gas ▪ nausea ▪ vomiting

Dosage and Administration (34068-7)

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.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

▪ fever ▪ bloody or black stool ▪ mucus in your stool

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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