The following Structured Product Label (SPL) was submitted to the FDA by Pekana Naturheilmittel Gmbh for the product Somcupin (NDC 59469-317). 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, inactive ingredient, otc - purpose, dosage, warning, otc - keep out of reach of children, storage and handling, tamper evident, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Ingredients: | |
|---|---|
| Argentum nitricum | 6X |
| Coffea arabica | 10X |
| Delphinium staphysagria (Staphisagria) | 6X |
| Eschscholzia californica | 12X |
| Lactuca virosa | 4X |
| Natrium tetrachloroauratum (Aurum chloratum natronatum) | 6X |
| Zincum valerianicum | 5X |
| Avena sativa | 53.40 mg/ml |
Selected ingredients prepared by spagyric processes.
Contains 27% alcohol by volume.
For occasional sleeplessness. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.
Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.
If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.
Keep out of the reach of children.
Protect from light and heat.
Do not use this product if tamper evident strip is broken or removed from base of cap.
To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931
Distributed by:
BioResource Inc.
Cotati, CA 94931
Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg
SOMCUPIN™
Oral Drops
Homeopathic Medicine
For occasional
sleeplessness
1.7 FL OZ
(50 ml)
PEKANA®
Principal Display Panel (50 ml Bottle Box)
* Please review the disclaimer below.
