Dr. Reckeweg R4 Enterocolin
FDA Label NDC 53346-1304

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 R4 Enterocolin (NDC 53346-1304). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients:
Baptisia tinctoria 4X, Chamomilla 4X, Chininum arsenicosum 6X, Colocynthis 6X, Ferrum phosphoricum 8X, Mercurius corrosivus 6X, Oleander 6X, Phosphoricum acidum 3X, Rhus toxicodendron 4X, Veratrum album 6X, 1 g each in 10 g.

Otc - Purpose


Purpose

Relieves diarrhea


Indications & Usage


Uses

For the temporary relief of:


  • Diarrhea

Warnings

Warnings

Otc - Stop Use

Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.

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 every 15-60 minutes (up to 12 times per day) or until improvement of symptoms, in a little water or undiluted or as recommended.

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 information.

Inactive Ingredient

Inactive ingredients

 Ethanol, purified water.

Package Label.Principal Display Panel

Image Of Carton Label (B8455c48 A727 4a2e 8e62 70affad974e3)

Image Of Carton Label (B8455c48 A727 4a2e 8e62 70affad974e3)

NDC# 53346-1304-5

Dr. Reckeweg R4 Enterocolin

Homeopathic preparation for the temporary relief of:

  • Diarrhea
  • Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany


    1.68 fl oz
    (50 ml

* Please review the disclaimer below.