Otc - Active Ingredient
Active ingredients
Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g.
Dr. Reckeweg R16 Cimisan
FDA Label NDC 53346-1316
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 R16 Cimisan (NDC 53346-1316). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Relieves migraine headache pain
Indications & Usage
Uses
For the temporary relief of:
- Migraine headache pain
Warnings
Warnings
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: acute cases: 5-10 drops (up to 6 times per day);
in chronic cases: 5-10 drops 3 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.
Otc - Questions
Questions?
Call 1-800-361-7872 or email [email protected]
Package Label.Principal Display Panel
Image Of Carton Label (Ae122ddf A5ea 4887 B6e6 F4393160b430)
NDC# 53346-1316-5
Dr. Reckeweg R16 Cimisan
Homeopathic preparation for the temporary relief of:
- Migraine headache pain
Manufactured by:
Dr. Reckeweg Co. GmbH
D-64625 Bensheim
Germany
1.68 fl oz
(50 ml)
* Please review the disclaimer below.
