Otc - Active Ingredient
ACTIVE INGREDIENTS (HPUS*): Arsenicum Album 30X, Coffea Cruda 30X, Kali Carbonica 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X
Insomnia Hp
FDA Label NDC 43406-0027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Insomnia Hp (NDC 43406-0027). 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, indications & usage, warnings, dosage & administration, otc - do not use, references, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
USES: Temporarily relieves sleeplessness due to anxiousness, excitement, exhaustion, nervousness, dreams, &/or other symptoms related to insomnia.
Warnings
WARNING:
Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.
Dosage & Administration
DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.
Otc - Do Not Use
OTHER INFORMATION: Tamper Seal: "Sealed for your protection."
Do not use if seal is broken or missing.
References
*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.
Inactive Ingredient
INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%
Otc - Questions
QUESTIONS AND COMMENTS?
MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600
LOT:
Otc - Purpose
USES: Temporarily relieves sleeplessness due to anxiousness, excitement, exhaustion, nervousness, dreams, &/or other symptoms related to insomnia.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.
Package Label.Principal Display Panel
NDC: 43406-0027-1
INSOMNIA HP
Insomnia
HOMEOPATHIC
1 fl oz (30 mL) / 20% Alcohol
UPC: 877730001719
Image Of Label (Insomniahp)
* Please review the disclaimer below.
