FDA Label for Dr. Reckeweg R14 Quieta Combination Product

View Indications, Usage & Precautions

Dr. Reckeweg R14 Quieta Combination Product Product Label

The following document was submitted to the FDA by the labeler of this product Pharmazeutische Fabrik Dr. Reckeweg & Co. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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.


Otc - Purpose




Purpose

Relieves sleeplessness caused by worry, overwork, stress and tension


Indications & Usage




Uses

For the temporary relief of:


  • Sleeplessness caused by worry, overwork, stress and tension

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

  • sleeplessness persists continuously for more than 2 weeks
  • sleeplessness may be a symptom of serious underlying medical 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 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 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.


Otc - Questions




Questions?

Call 1-800-361-7872 or email [email protected]


Package Label.Principal Display Panel



NDC# 53346-1314-5

Dr. Reckeweg R14 Quieta

Homeopathic preparation for the temporary relief of:

  • Sleeplessness caused by worry, overwork, stress and tension
  • Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)


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