dr. reckeweg r7 hepagalen

SPL v1

SPL

SPL Set ID dac7bc58-649e-493b-92e0-b164ca43b3dd

Route

oral

Published

Effective Date 2013-04-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

silybum marianum seed (2 [hp_X]) chelidonium majus root (3 [hp_X]) cinchona bark (6 [hp_X]) cholesterol (4 [hp_X]) citrullus colocynthis fruit pulp lycopodium clavatum spore strychnos nux-vomica seed

Inactive Ingredients

alcohol water

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 1986-06-01

Description

Active ingredients Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X, 1 g each in 10 g.

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredients

Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X, 1 g each in 10 g.

Indications and Usage

Uses

For the temporary relief of:

Digestive sluggishness
Constipation
Flatulence

Dosage and Administration

Directions

Adults and children ≥ 12 years 10-15 drops 1-3 times daily; acute cases: 10-15 drops 3-6 times daily in a little water or undiluted or as recommended.

Not recommended for children under 12 years of age except under the advice of a health care professional.

Description

Active ingredients Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X, 1 g each in 10 g.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement after use of a laxative occurs because this may indicate a serious condition
symptoms persist over a period of more than 1 week.

Section 50569-3

Ask a doctor before use if you have

abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor before use

in children younger than 12 years.

Section 51727-6

Inactive ingredients

Ethanol, purified water.

Section 51945-4

NDC# 53346-1307-5

Dr. Reckeweg R7 Hepagalen

Homeopathic preparation for the temporary relief of:

Digestive sluggishness
Constipation
Flatulence

Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

1.68 fl oz

(50 ml)

Section 53413-1

Questions?

Call 1-800-361-7872 or email [email protected]

Section 53414-9

If pregnant or breastfeeding, ask a health care professional before use.

Section 55105-1

Purpose

Relieves digestive sluggishness, constipation, flatulence

Section 60561-8

Other information

Tamper resistant: Do not use if safety ring at base of cap is broken.

Retain outer carton for full product instructions.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients

Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X, 1 g each in 10 g.

Indications and Usage (34067-9)

Uses

For the temporary relief of:

Digestive sluggishness
Constipation
Flatulence

Dosage and Administration (34068-7)

Directions

Adults and children ≥ 12 years 10-15 drops 1-3 times daily; acute cases: 10-15 drops 3-6 times daily in a little water or undiluted or as recommended.

Not recommended for children under 12 years of age except under the advice of a health care professional.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement after use of a laxative occurs because this may indicate a serious condition
symptoms persist over a period of more than 1 week.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor before use

in children younger than 12 years.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol, purified water.

Section 51945-4 (51945-4)

NDC# 53346-1307-5

Dr. Reckeweg R7 Hepagalen

Homeopathic preparation for the temporary relief of:

Digestive sluggishness
Constipation
Flatulence

Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

1.68 fl oz

(50 ml)

Section 53413-1 (53413-1)

Questions?

Call 1-800-361-7872 or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health care professional before use.

Section 55105-1 (55105-1)

Purpose

Relieves digestive sluggishness, constipation, flatulence

Section 60561-8 (60561-8)

Other information

Tamper resistant: Do not use if safety ring at base of cap is broken.

Retain outer carton for full product instructions.

Advanced Ingredient Data

[{"name": "SILYBUM MARIANUM SEED", "unii": "U946SH95EE", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CHELIDONIUM MAJUS ROOT", "unii": "FLT36UCF0N", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CINCHONA BARK", "unii": "292E43P4I9", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CHOLESTEROL", "unii": "97C5T2UQ7J", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CITRULLUS COLOCYNTHIS FRUIT PULP", "unii": "23H32AOH17", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "LYCOPODIUM CLAVATUM SPORE", "unii": "C88X29Y479", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of: Digestive sluggishness Constipation Flatulence", "34068-7": "Directions Adults and children ≥ 12 years 10-15 drops 1-3 times daily; acute cases: 10-15 drops 3-6 times daily in a little water or undiluted or as recommended. Not recommended for children under 12 years of age except under the advice of a health care professional.", "34071-1": "Warnings", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement after use of a laxative occurs because this may indicate a serious condition symptoms persist over a period of more than 1 week.", "50569-3": "Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks. Ask a doctor before use in children younger than 12 years.", "51727-6": "Inactive ingredients Ethanol, purified water.", "51945-4": "NDC# 53346-1307-5 Dr. Reckeweg R7 Hepagalen Homeopathic preparation for the temporary relief of: Digestive sluggishness Constipation Flatulence Manufactured by: Dr. Reckeweg Co. GmbH D-64625 Bensheim Germany 1.68 fl oz (50 ml)", "53413-1": "Questions? Call 1-800-361-7872 or email questions@reckeweg.com", "53414-9": "If pregnant or breastfeeding , ask a health care professional before use.", "55105-1": "Purpose Relieves digestive sluggishness, constipation, flatulence", "55106-9": "Active ingredients Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X, 1 g each in 10 g.", "60561-8": "Other information Tamper resistant: Do not use if safety ring at base of cap is broken. Retain outer carton for full product instructions."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:12.456615 · Updated: 2026-03-14T23:14:24.460770