Dr. Reckeweg R5 Gastreu
FDA Label NDC 53346-1305

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 R5 Gastreu (NDC 53346-1305). 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.

Otc - Active Ingredient

Active ingredients:

Anacardium orientale 6X, Argentum nitricum 6X, Arsenicum album 6X, Belladonna 4X, Carbo vegetabilis 8X, Chamomilla 2X, Chelidonium majus, radix 3X, Lycopodium clavatum 5X, Nux vomica 4X, Scrophularia nodosa 1X, 1 g each in 10 g.

Otc - Purpose


Purpose

Relieves heartburn, sour stomach, acid indigestion


Indications & Usage


Uses

For the temporary relief of:


  • Heartburn
  • Sour stomach
  • Acid indigestion

Warnings

Warnings

Otc - Ask Doctor

Ask a doctor before use

  • in children younger than 12 years.

Otc - Stop Use

Stop use and ask a doctor if

  • symptoms persist over a period of more than 7 days
  • symptoms worsen or if new symptoms occur, because these could be signs of serious illness.  

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 3 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 information.

Inactive Ingredient

Inactive ingredients

Ethanol, purified water.

Package Label.Principal Display Panel

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NDC# 53346-1305-5

Dr. Reckeweg R5 Gastreu

Homeopathic preparation for the temporary relief of:

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany


    1.68 fl oz
    (50 ml)

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