Insomnia
FDA Label NDC 68428-021

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Washington Homeopathic Products for the product Insomnia (NDC 68428-021). 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, uses, keep out of reach of children, indications, stop use and ask doctor, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

CHAMOMILLA    6C

COFFEA CRUDA    6C

HYOSCYAMUS   6C

IGNATIA       6C

PASSIFLORA  6C

Uses

To relieve the symptoms of caused by grief, intense mental application, stress. Non-habit forming. Will not cause drowsiness.

Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children.

Indications

Indications:

CHAMOMILLA    Irritability

COFFEA CRUDA    Sleeplessness

HYOSCYAMUS   Twitching

IGNATIA       Sadness

PASSIFLORA  Insomnia

Stop Use And Ask Doctor

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

Directions

Adults 2 pellets every 3 hours for 2 days. Then 2 pellets morning and night for 2 weeks.

Children: 1 pellet. Repeat as necessary.

Inactive Ingredients

Sucrose/Lactose

Principal Display Panel

Image Of Bottle Label (Insomnia)

Image Of Bottle Label (Insomnia)

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