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Kalmia latifolia - Prescription Drug Labeling

Product NDC Code 68428-458
Drug Name

Kalmia latifolia

Type Brand
Active Ingredients
Kalmia latifolia leaf 30 [hp_c]/1
Route ORAL
Dosage Form PELLET
Labeler Name Washington Homeopathic Products
Packages
Package NDC Code Description
68428-458-03 75 pellet in 1 vial, glass (68428-458-03)
68428-458-05 150 pellet in 1 vial, glass (68428-458-05)
68428-458-06 1200 pellet in 1 bottle, glass (68428-458-06)
68428-458-11 300 pellet in 1 bottle, glass (68428-458-11)
68428-458-12 600 pellet in 1 bottle, glass (68428-458-12)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS KALMIA

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: KALMIA Lumbar pain

Purpose

Information about the drug product’s indications for use.
USES To relieve the symptoms of lumbar pain.

Spl product data elements

Usually a list of ingredients in a drug product.
Kalmia latifolia KALMIA LATIFOLIA LEAF SUCROSE LACTOSE KALMIA LATIFOLIA LEAF KALMIA LATIFOLIA LEAF 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 KALMIA is 3x–30x, 2c–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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API