Milk Of Magnesia
Cardinal Health 107, Llc
Human Otc Drug
NDC 55154-9403Milk Of Magnesia is a human otc drug labeled by 'Cardinal Health 107, Llc'. National Drug Code (NDC) number for Milk Of Magnesia is 55154-9403. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Milk Of Magnesia drug includes Magnesium Hydroxide - 2400 mg/30mL . The currest status of Milk Of Magnesia drug is Active.
Drug Information:
| Drug NDC: | 55154-9403 |
| 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: | Milk Of Magnesia |
| 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: | Milk Of Magnesia |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health 107, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension |
| 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: | MAGNESIUM HYDROXIDE - 2400 mg/30mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 07 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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. |
| Application Number: | part331 |
| 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. |
| 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: | Cardinal Health 107, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 253017
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0055154940351
|
| UPC stands for Universal Product Code. |
| UNII: | NBZ3QY004S
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 55154-9403-5 | 5 CUP, UNIT-DOSE in 1 BAG (55154-9403-5) / 30 mL in 1 CUP, UNIT-DOSE | 07 Jun, 2011 | 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. |
Purpose:
Purpose saline laxative
Product Elements:
Milk of magnesia milk of magnesia magnesium hydroxide hydroxide ion hypromellose, unspecified methylparaben potassium citrate propylene glycol propylparaben water saccharin sodium sorbitol
Indications and Usage:
Uses as an antacid ⢠heartburn ⢠upset/sour stomach ⢠acid indigestion as a laxative (usually within ½ to 6 hours) ⢠occasional constipation (irregularity)
Warnings:
Warnings ask a doctor before use if you have ⢠kidney disease ⢠a magnesium-restricted diet ⢠stomach pain, nausea, or vomiting ⢠a sudden change in bowel habits that lasts over 14 days ask a doctor or pharmacist before use if you are taking a prescription drug. this product may interact with certain prescription drugs. stop use and ask a doctor if ⢠you have rectal bleeding or no bowel movement after using this product. these could be signs of a serious condition. ⢠you need to use a laxative for more than 1 week if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions as an antacid ⢠do not exceed the maximum recommended daily dose in a 24 hour period ⢠shake well before use ⢠can be taken with water ⢠ml = milliliter adults and children 12 years of age and over 5 to 15 ml (1 to 3 teaspoonfuls) children under 12 years of age ask a doctor as a laxative ⢠do not exceed the maximum recommended daily dose of 60 ml in a 24 hour period ⢠shake well before use ⢠dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor. drink a full glass (8 oz) of liquid with each dose. ⢠ml = milliliter; tbsp = tablespoon adults and children 12 years and older 30 ml (2 tbsp) to 60 ml (4 tbsp) children 6 â 11 years 15 ml (1 tbsp) to 30 ml (2 tbsp) children under 6 years ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠you have rectal bleeding or no bowel movement after using this product. these could be signs of a serious condition. ⢠you need to use a laxative for more than 1 week
Package Label Principal Display Panel:
Principal display panel milk of magnesia usp 5 cups bag label
Further Questions:
Questions or comments? call 1-800-845-8210