NDC 0904-6787 Citroma

Magnesium Citrate

NDC Product Code 0904-6787

NDC 0904-6787-44

Package Description: 296 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Citroma with NDC 0904-6787 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Citroma is magnesium citrate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Citroma 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 CITRATE 1.745 g/29.6mL

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: Major Pharmaceuticals
Labeler Code: 0904
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: 02-18-2018 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’.

* Please review the disclaimer below.

Citroma Product Label Images

Citroma 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

Active Ingredient

Magnesium citrate 1.745g per fl oz

Purpose

Saline laxative

Use

For relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours

Warnings

For this product

Ask A Doctor

  • Before use if you havekidney diseasea magnesium restricted dietabdorominal pain, nausea, or vomitingnoticed a sudden change in bowel habits that persists over a period of 2 weeksalready used a laxative for a period longer than 1 week

Ask A Doctor Or Pharmacist

Before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop Use

And ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

Ask health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right awayStore at temperatures between 46° and 86°F (8° and 30° C)

Directions

  • Drink a full glass (8 ounces) of liquid with each dosemay be taken as a single daily dose or in divided dosesadults and children 12 years of age and over - 6.5 to 10 fl oz in 24 hourschildren 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hourschildren 2 to under 6 years of age - 2 to 3 fl oz in 24 hourschildren under 2 years of age - ask a doctor

Other Information

  • Each fl oz contains: magnesium 295 mgeach fl oz contains: sodium 1 mg

Inactive Ingredients

Benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Adverse Reaction

Distributed by: MAJOR PHARMACEUTICALS17177 N Laurel Park Drive, Suire 233Livonia, MI 48152Re-Order No.014432 M-97Rev. 10/16

* Please review the disclaimer below.