NDC 30400-210 Epsom Salts

Magnesium Sulfate

NDC Product Code 30400-210

NDC Product Information

Epsom Salts with NDC 30400-210 is a a human over the counter drug product labeled by Jell Pharmaceuticals Pvt. Ltd.. The generic name of Epsom Salts is magnesium sulfate. The product's dosage form is granule and is administered via oral form.

Labeler Name: Jell Pharmaceuticals Pvt. Ltd.

Dosage Form: Granule - A small particle or grain.

Product Type: Human Otc Drug 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.

Epsom Salts Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM SULFATE HEPTAHYDRATE 100 g/100g

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.

Labeler Name: Jell Pharmaceuticals Pvt. Ltd.
Labeler Code: 30400
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 07-09-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Sodium Phosphate

Sodium Phosphate is pronounced as (soe' dee um) (fos' fate)

Why is sodium phosphate medication prescribed?
Sodium phosphate is used in adults 18 years of age or older to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to ch...
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Epsom Salts Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredients PurposeMagnesium Sulfate (heptahydrate) 100% Saline Laxative

Otc - Purpose

  • UsesFor relief of Occasional Constipation (Irregularity)This product generally produces bowel movement

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications & Usage

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after any other drugs. Laxative may affect how other drugs work.

Warnings

  • WarningsAsk a doctor before use if you haveKidney DiseaseA magnesium restricted dietAbdominal pain, nausea or vomitingNoticed a sudden change in bowel habits that persists over a period of 2 weeksAlready used a laxative for a period of longer than 1 weekIf pregnant or breast-feeding ask a health profesional before use

Dosage & Administration

  • Directionsdo not exceed more than 2 doses per daydrink a full glass (8 ounces) of liquid with each dosedissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.adults and children 12 years and over: 2 to 4 level teaspoons (10 to 20 grams) dailychildren 6 to under 12 years: 1 to 2 level teaspoons (5 to 10 grams) dailychildren under 6 years: consult a doctor

Inactive Ingredient

There are no inactive ingredients

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