Menstrual Cramps

Magnesium Phosphate, Dibasic Trihydrate, Citrullus Colocynthis Fruit Pulp, Black Cohosh, And Pulsatilla Vulgaris

Hyland's Inc.
Human Otc Drug
NDC 54973-2961

Menstrual Cramps also known as Magnesium Phosphate, Dibasic Trihydrate, Citrullus Colocynthis Fruit Pulp, Black Cohosh, And Pulsatilla Vulgaris is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Menstrual Cramps is 54973-2961. This drug is available in dosage form of Tablet, Soluble. The names of the active, medicinal ingredients in Menstrual Cramps drug includes Black Cohosh - 12 [hp_X]/1 Citrullus Colocynthis Fruit Pulp - 12 [hp_X]/1 Magnesium Phosphate, Dibasic Trihydrate - 12 [hp_X]/1 Pulsatilla Vulgaris - 6 [hp_X]/1 . The currest status of Menstrual Cramps drug is Active.

Drug Information:

Drug NDC:	54973-2961
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Menstrual Cramps
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Magnesium Phosphate, Dibasic Trihydrate, Citrullus Colocynthis Fruit Pulp, Black Cohosh, And Pulsatilla Vulgaris
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Soluble
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BLACK COHOSH - 12 [hp_X]/1 CITRULLUS COLOCYNTHIS FRUIT PULP - 12 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 12 [hp_X]/1 PULSATILLA VULGARIS - 6 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	18 Apr, 1995
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Hyland's Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	K73E24S6X9 23H32AOH17 HF539G9L3Q I76KB35JEV
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Calculi Dissolution Agent [EPC] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
54973-2961-2	100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-2961-2)	18 Apr, 1995	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Menstrual Cramps

Magnesium Phosphate & more..

Tablet, Soluble
Hyland's Inc.
NDC: 54973-2961

Purpose:

Hyland's menstrual cramps is a traditional homeopathic formula for the relief of symptoms of cramps associated with the menstrual period. working without contraindications or side effects, hyland's menstrual cramps stimulates your body's natural healing response to relieve symptoms. hyland's menstrual cramps can be used in conjunction with other medications.

Product Elements:

Menstrual cramps magnesium phosphate, dibasic trihydrate, citrullus colocynthis fruit pulp, black cohosh, and pulsatilla vulgaris lactose magnesium phosphate, dibasic trihydrate magnesium cation citrullus colocynthis fruit pulp citrullus colocynthis fruit pulp black cohosh black cohosh pulsatilla vulgaris pulsatilla vulgaris

Indications and Usage:

Indications relief of symptoms of menstrual cramping, especially those which radiate, are made better by pressure and heat, and are made worse by motion.

Warnings:

Warnings do not use if imprinted cap band is broken or missing. if symptoms persist for more than seven days or worsen, contact a licensed health care professional. as with any drug, if your are pregnant or nursing a baby, seek the advice of a licensed health care professional before using this product. keep this and all medications out of the reach of children. in case of accidental overdose, contact a poison control center immediately.

Do Not Use:

Dosage and Administration:

Directions adults: dissolve 2-3 tablets under tongue every 4 hours or as needed.

Package Label Principal Display Panel:

Principal display panel - 100 tablet bottle carton ndc 54973-2961-02 hyland's Â® homeopathic menstrual cramps natural relief for menstrual pain. 100 tablets carton

Further Questions:

Questions? call us: 800/624-9659

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.