NDC 63083-2137 Pre-labor Drops 2137
Liquid Oral

Product Information

What is NDC 63083-2137?

The NDC code 63083-2137 is assigned by the FDA to the product Pre-labor Drops 2137 which is a human over the counter drug product labeled by Professional Complementary Health Formulas. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 63083-2137-2 59 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63083-2137
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.
Pre-labor Drops 2137
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.
Pre-labor Drops
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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Professional Complementary Health Formulas
Labeler Code63083
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.
08-15-1984
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.
12-31-2023
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 Pre-labor Drops 2137?


Product Packages

NDC Code 63083-2137-2

Package Description: 59 mL in 1 BOTTLE, DROPPER

Product Details

What are Pre-labor Drops 2137 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.

Pre-labor Drops 2137 Active Ingredients UNII Codes

  • ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
  • ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (Active Moiety)
  • CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
  • CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (Active Moiety)
  • BLACK COHOSH (UNII: K73E24S6X9)
  • BLACK COHOSH (UNII: K73E24S6X9) (Active Moiety)
  • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q)
  • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (Active Moiety)
  • PULSATILLA MONTANA WHOLE (UNII: 24K790T39B)
  • PULSATILLA MONTANA WHOLE (UNII: 24K790T39B) (Active Moiety)

Pre-labor Drops 2137 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.

* Please review the disclaimer below.

Pre-labor Drops 2137 Product Label

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.

Product Label Table of Contents



Active Ingredients



Arnica montana 5C
Caulophyllum thalictroides 5C
Cimicifuga racemosa 5C
Gelsemium sempervirens 5C
Pulsatilla 5C


Questions



Professional Formulas

PO Box 2034 Lake Oswego, OR 97035


Indications



For the temporary relief of occasional headache, minor backache, swelling or aches in legs, or fatigue that is common during pregnancy.*


Otc - Purpose



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings



In case of overdose, get medical help or contact a poison control center right away.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a healthcare professional before use.


Directions



Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age. Not intended for use in infants.


Other Information



Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.


Inactive Ingredients



10% ethanol, purified water, 8% vegetable glycerin (from soy).


Label



Est 1985

Professional Formulas

Complementary Health

Pre-Labor Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)


* Please review the disclaimer below.