Active ingredient A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS PAEONIA
Dosage and administration Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Sucrose/Lactose
Indications and usage A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
INDICATIONS Indications: PAEONIA Hemorrhoids
Purpose Information about the drug product’s indications for use.
USES To relieve the symptoms of hemorrhoids.
Spl product data elements Usually a list of ingredients in a drug product.
Paeonia officinalis PAEONIA OFFICINALIS ROOT SUCROSE LACTOSE PAEONIA OFFICINALIS ROOT PAEONIA OFFICINALIS ROOT white
Package label principal display panel The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL The OTC potency range of PAEONIA is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM. Availability is subject to change. 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’ and ‘Potency’ vary on the label depending on customer choice. Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce. Label
Keep out of reach of children Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children.
Warnings Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.