Dr. Reckeweg R7 Hepagalen
FDA Label NDC 53346-1307

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmazeutische Fabrik Dr. Reckeweg & Co for the product Dr. Reckeweg R7 Hepagalen (NDC 53346-1307). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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.

Otc - Purpose


Purpose

Relieves digestive sluggishness, constipation, flatulence


Indications & Usage


Uses

For the temporary relief of:


  • Digestive sluggishness
  • Constipation
  • Flatulence

Warnings

Warnings

Otc - Ask Doctor

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

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & 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.

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

Inactive ingredients

Ethanol, purified water.

Package Label.Principal Display Panel

Image Of Carton Label (E7966e97 7072 42cd B9ed 491f9e3a5163)

Image Of Carton Label (E7966e97 7072 42cd B9ed 491f9e3a5163)

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)

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