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  5. Label Information: Dr. Reckeweg R34 Calcossin Combination Product

FDA Label for Dr. Reckeweg R34 Calcossin Combination Product

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Reckeweg R34 Calcossin 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

Calcarea carbonica 30X, Calcarea fluorica 12X, Calcarea hypophosphorosa 6X, Calcarea phosphorica 12X, Chamomilla 6X, Hekla Lava 12X, Mercurius praecipitatus ruber 12X, Mezereum 6X, Silicea 30X,  

1 g each in 10 g.


Otc - Purpose



Purpose

Relieves symptoms associated with osteoporosis in adults and bone growth in children


Indications & Usage



Uses

For the temporary relief of minor symptoms associated with osteoporosis in adults and bone growth in children such as:

  • Minor pain in bones
  • Demineralization

Warnings



Warnings


Otc - Do Not Use



Do not use

  • if allergic to plants of the daisy (Asteraceae/Compositae) family.



Otc - Ask Doctor



Ask a doctor before use

  • in children at the age of 2-11 years.

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 a little water or undiluted or as recommended. For children (2-11 years): consult a health care professional before use.


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



image of carton label - b3d3c578 4872 4a94 80e1 bcaf42087ed9

image of carton label - b3d3c578 4872 4a94 80e1 bcaf42087ed9

NDC# 53346-1334-5

Dr. Reckeweg R34 Calcossin

Homeopathic preparation for the temporary relief of minor symptoms associated with osteoporosis and bone growth in children such as:

  • Minor pain in bones
  • Demineralization


    • Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

                                         
    1.68 fl oz
    (50 ml)


* Please review the disclaimer below.