Otc - Active Ingredient
ACTIVE INGREDIENTS: Arsenicum album 30X, Coffea cruda 30X, Kali carbonicum 30X, Magnesia carbonica 30X, Nux vomica 30X, Passiflora incarnata 30X, Sepia 30X, Valeriana officinalis 30X.
Insomnia Plus
FDA Label NDC 57520-0611
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Insomnia Plus (NDC 57520-0611). 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, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For the temporary relief of fatigue, and restlessness from inability to sleep.
Warnings
WARNINGS: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.
Do not use if tamper evident seal is broken or missing.
Dosage & Administration
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Inactive Ingredient
INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
INDICATIONS: For the temporary relief of fatigue, and restlessness from inability to sleep.
Otc - Questions
Distributed by:
SYNERGY FORMULAS, INC.
251 West Road
Campobello, SC 29322
Package Label.Principal Display Panel
Synergy Formulas
INSOMNIA PLUS
HOMEOPATHIC
2 FL OZ (60 ml)
Insomnia Plus (Mm1)
* Please review the disclaimer below.
