Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID feb6c271-182d-4a4c-bb2d-d1a87c76c7ef

Route

ORAL

Published

Effective Date 2014-02-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Citrullus Colocynthis Fruit Pulp (6 [hp_X]) Magnesium Phosphate, Dibasic Chamomile Dioscorea Villosa Root

Inactive Ingredients

Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2014-02-19

Description

Colocynthis (Bitter apple) 6X Magnesia phosphorica (Magnesium hydrogen phosphate) 6X Chamomilla (German chamomile) 6X Dioscorea villosa (Wild yam) 6X *The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Purpose

Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain

Medication Information

Purpose

Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps

Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability

Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain

Description

Uses

This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic:

• intestinal gas

• abdominal pain

• bloating & hiccups

• nausea

• burping

• upset stomach

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Carton

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

Section 50570-1

Do not use if inner foil seal is broken or missing.

Warnings

Directions

• Do not use more than directed.

• Take 0.75 mL orally at the onset of symptoms.

• Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional.

Age Dose

Infants and children 0 to 9 years of age 0.75 mL

Other Information

Store at room temperature.

Inactive Ingredients

Purified water, sorbitol, raspberry and grape flavor, sodium benzoate, potassium sorbate, citric acid.

Active Ingredients Hpus*

Colocynthis (Bitter apple) 6X

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X

Chamomilla (German chamomile) 6X

Dioscorea villosa (Wild yam) 6X

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

Structured Label Content

Uses

This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic:

• intestinal gas

• abdominal pain

• bloating & hiccups

• nausea

• burping

• upset stomach

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Carton (CARTON)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

Section 50570-1 (50570-1)

Do not use if inner foil seal is broken or missing.

Purpose

Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps

Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability

Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain

Warnings

Directions

• Do not use more than directed.

• Take 0.75 mL orally at the onset of symptoms.

• Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional.

Age Dose

Infants and children 0 to 9 years of age 0.75 mL

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

Purified water, sorbitol, raspberry and grape flavor, sodium benzoate, potassium sorbate, citric acid.

Active Ingredients Hpus* (Active ingredients HPUS*)

Colocynthis (Bitter apple) 6X

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X

Chamomilla (German chamomile) 6X

Dioscorea villosa (Wild yam) 6X

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

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRULLUS COLOCYNTHIS FRUIT PULP", "unii": "23H32AOH17", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "25", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MAGNESIUM PHOSPHATE, DIBASIC", "unii": "A1Y870209Z", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "25", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "25", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "DIOSCOREA VILLOSA ROOT", "unii": "IWY3IWX2G8", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "25", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic: • intestinal gas • abdominal pain • bloating & hiccups • nausea • burping • upset stomach *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.", "50570-1": "Do not use if inner foil seal is broken or missing.", "Purpose": "Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain", "Directions": "• Do not use more than directed. • Take 0.75 mL orally at the onset of symptoms. • Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional. Age Dose Infants and children 0 to 9 years of age 0.75 mL", "Other information": "Store at room temperature.", "Inactive ingredients": "Purified water, sorbitol, raspberry and grape flavor, sodium benzoate, potassium sorbate, citric acid.", "Active ingredients HPUS*": "Colocynthis (Bitter apple) 6X Magnesia phosphorica (Magnesium hydrogen phosphate) 6X Chamomilla (German chamomile) 6X Dioscorea villosa (Wild yam) 6X *The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:37.766039 · Updated: 2026-03-14T23:17:41.257754