Active Ingredients
Avena sativa 1X
Asafoetida 3X
Corydalis canadensis 3X
Hyoscyamus niger 3X
Sumbul 6X
Valeriana officinalis 3X
Cicuta virosa 4X
Ignatia amara 4X
Olei gaultheria procumbens 4X
Staphysagria 4X
Distress Drops Liquid
FDA Label NDC 63083-2121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Distress Drops (NDC 63083-2121). 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 active ingredients, questions, indications, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Questions
Professional Formulas
PO Box 2034 Lake Oswego, OR 97035
Indications
For the temporary relief of feeling distressed or a tendency towards overreaction.*
Otc - Purpose
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings
In case of overdose, get medical help or contact a poison control center right away.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a healthcare professional before use.
Directions
Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.
Other Information
Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.
Inactive Ingredients
20% ethanol, purified water.
Label
Est 1985
Professional Formulas
Complementary Health
Distress Drops
Homeopathic Remedy
2 FL. OZ. (59 mL)
Label Image (C121 Thumb)
* Please review the disclaimer below.
