NDC 53645-1141 Apis Mell.
Globule Oral

Product Information

Apis Mell. is a human over the counter drug product labeled by True Botanica, Llc. The product's dosage form is globule and is administered via oral form.

Product Code53645-1141
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Apis Mell.
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Apis Mell.
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormGlobule - Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
True Botanica, Llc
Labeler Code53645
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-20-2013
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Apis Mell.?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)4 MM
Score1

Product Packages

NDC 53645-1141-2

Package Description: 23 g in 1 BOTTLE

Product Details

What are Apis Mell. Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Apis Mell. Active Ingredients UNII Codes

Apis Mell. Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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Apis Mell. Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Apis Mell. 30X, HPUS

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.


Otc - Purpose



Enter section text here


Use:



For temporary relief of fever, inflammation, joint pain. May also be used for standard homeopathic indications or as directed by your physician.


Warnings:



Consult your health care provider if symptoms persist more than 5 days or worsen.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Do Not Use



TAMPER EVIDENT: Do not use if safety seal is broken before first use.


Directions For Use:



Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3
 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.


Other Ingredients:



Sucrose


Otc - Questions





Developed and Made by

True Botanica, LLC

1005 Richards Rd., Suite D

Hartland, WI 53029

800-315-8783

www.truebotanica.com


* Please review the disclaimer below.