Active Ingredients
PASSIFLORA
Passiflora Incarnata
FDA Label NDC 71919-521
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 Passiflora Incarnata (NDC 71919-521). 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.
Label Section Quick Index
Uses
To relieve the symptoms of insomnia.
Keep Out Of Reach Of Children
Keep this and all medicines out of reach of children.
Indications
Indications:
PASSIFLORA Insomnia
Stop Use And Ask Doctor
If symptoms persist/worsen or if pregnant/nursing, consult your practitioner.
Directions
Adults: 4 drops into a tsp. of water 3 times a day. Children: 1/2 dose. Repeat at greater intervals as condition subsides. Or as directed bya lic. practitioner.
Inactive Ingredients
Sucrose/Lactose
Principal Display Panel
The OTC potency range of PASSIFLORA is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.
Availability is subject to change.
Passiflora Label Example (Passiflora30c30ml Label)
All WHP single remedies are made to order; thus, the labels are printed on the same label stock, as the orders are filled.
‘Bottle Size,’ ‘Potency,’ and ‘Alcohol Percentage’ vary on the label depending on customer choice.
Standard bottle sizes for dilution-form remedies are 15ml, 30ml, 50ml, and 100ml.
* Please review the disclaimer below.
