The following Structured Product Label (SPL) was submitted to the FDA by Pharmazeutische Fabrik Dr. Reckeweg & Co for the product Dr. Reckeweg R14 Quieta (NDC 53346-1314). 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.
Active ingredients
Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X,
Valeriana officinalis 1X, Zincum valerianicum 6X, 1 g each in 10 g.
Purpose
Relieves sleeplessness caused by worry, overwork, stress and tension
Uses
For the temporary relief of:
Warnings
Ask a doctor before use in children younger than 12 years.
Stop use and ask a doctor if
If pregnant or breastfeeding, ask a health care professional before use.
Keep out of reach of children.
Directions
Adults and children ≥ 12 years 5-10 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 information
Inactive ingredients
Ethanol, purified water.
Image Of Carton Label (B3f078a8 34d3 4202 8f73 7450a1b31fd6)
NDC# 53346-1314-5
Dr. Reckeweg R14 Quieta
Homeopathic preparation for the temporary relief of:
Manufactured by:
Dr. Reckeweg Co. GmbH
D-64625 Bensheim
Germany
1.68 fl oz
(50 ml)
* Please review the disclaimer below.
