FDA.reportPublic FDA data

DR. RECKEWEG R7 Hepagalen

Manufacturer
PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO
Effective date
2013-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:33

Label at a glance#

ProductDR. RECKEWEG R7 Hepagalen Combination Product
Active ingredientSILYBUM MARIANUM SEED, CHELIDONIUM MAJUS ROOT, CINCHONA BARK, CHOLESTEROL, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION


Purpose

Relieves digestive sluggishness, constipation, flatulence


INDICATIONS & USAGE SECTION


Uses

For the temporary relief of:


  • Digestive sluggishness
  • Constipation
  • Flatulence

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before useif 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.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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.

OTHER SAFETY INFORMATION

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

Retain outer carton for full product instructions.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethanol, purified water.

OTC - QUESTIONS SECTION


Questions?

Call 1-800-361-7872 or email questions@reckeweg.com




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton label
image of carton label

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)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53346-1307-52020-01-31C16284748780-19d75b9d1-17f4-f424-e053-dadaa90a57ceDR. RECKEWEG R7 Hepagalen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53346-1307-5DR. RECKEWEG R7 HepagalenCombination Product50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53346-1307DR. RECKEWEG R7 HEPAGALEN COMBINATION PRODUCT (CARDUUS MARIANUS 2X, CHELIDONIUM MAJUS, RADIX 2X, CINCHONA 3X, CHOLESTERINUM 6X, COLOCYNTHIS 6X, LYCOPODIUM CLAVATUM 4X, NUX VOMICA 4X) LIQUID [PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO]1Legacy NDC, 1 package rows20130429_dac7bc58-649e-493b-92e0-b164ca43b3dd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHELIDONIUM MAJUS ROOTACTIVE INGREDIENTFLT36UCF0N1
CHOLESTEROLACTIVE INGREDIENT97C5T2UQ7J1
CINCHONA BARKACTIVE INGREDIENT292E43P4I91
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
CHELIDONIUM MAJUS ROOTACTIVE MOIETYFLT36UCF0N1
CHOLESTEROLACTIVE MOIETY97C5T2UQ7J1
CINCHONA BARKACTIVE MOIETY292E43P4I91
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53346-130753346-1307-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILYBUM MARIANUM SEEDU946SH95EEACTIB
CHELIDONIUM MAJUS ROOTFLT36UCF0NACTIB
CINCHONA BARK292E43P4I9ACTIB
CHOLESTEROL97C5T2UQ7JACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
e7966e97-7072-42cd-b9ed-491f9e3a5163dac7bc58-649e-493b-92e0-b164ca43b3dd2013-04-03WarningsExact identifier
spl id: e7966e97-7072-42cd-b9ed-491f9e3a5163
spl set id: dac7bc58-649e-493b-92e0-b164ca43b3dd

Reported adverse events (FAERS/openFDA)#

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