Dr. Reckeweg R81 Maldol
FDA Label NDC 53346-1381

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 R81 Maldol (NDC 53346-1381). 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 - do not use, 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

Cyclamen europaeum 4X 2 g, Ginkgo biloba 3X 2 g, Aranea diadema 4X, Cimicifuga racemosa 4X, Cocculus indicus 4X, Colocynthis 4X, Gelsemium sempervirens 3X, Spigelia anthelmia 4X, 1 g each in 10 g.

Otc - Purpose


Purpose

Relieves headaches and pain due to rheumatism, arthritis


Indications & Usage


Uses
For the temporary relief of headaches and pain due to:


  • Rheumatism
  • Arthritis

Warnings

Warnings

Otc - Do Not Use

Do not use

  • if hypersensitive to Ginkgo biloba.

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 5-10 drops 1-3 times daily, in acute cases 4-6

times daily 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

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NDC# 53346-1381-5

Dr. Reckeweg R81 Maldol

Homeopathic preparation for the temporary relief of headaches and pain due to:

  • Rheumatism
  • Arthritis

    • Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

* Please review the disclaimer below.