Warnings
Stop use and ask doctor if symptoms worsen or persist longer than 7 days.
If pregnant or breast-feeding, ask health professional before use.
Do not use if tamper evident seal is missing or broken.
Combination Remedy 20 - Insomnia
FDA Label NDC 69008-4070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Warsan Homoeopathic Laboratories for the product Combination Remedy 20 - Insomnia (NDC 69008-4070). 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 warnings, otc - keep out of reach of children, otc - active ingredient, otc - purpose, inactive ingredient, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Active Ingredient
Coffea Cruda 1X
Hyoscyamus Niger 1X
Ignatia Amara 1X
Passiflora Incarnata 1X
Valeriana Officinalis 1x
Otc - Purpose
Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.
Inactive Ingredient
Purified Water
Alcohol
Dosage & Administration
Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.
Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.
Children under 2 years: Consult doctor prior to use.
Indications & Usage
Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.
* Please review the disclaimer below.
