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| Product NDC Code | 69339-153 | ||||
|---|---|---|---|---|---|
| Drug Name | Milk of magnesia |
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| Type | Brand | ||||
| Pharm 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 253017 | ||||
| Application Number | M007 | ||||
| Labeler Name | Natco Pharma USA LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each 30 mL cup) Magnesium hydroxide 2400 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions shake well before use do not exceed the maximum recommended daily dose in a 24-hour period dose may be taken once a day preferably at bedtime, or as directed by a doctor drink a full glass (8 oz) of liquid with each dose adults and children 12 years and older 30ml, not more than 60ml in 24 hrs children under 12 years of age ask a doctor
| adults and children 12 years and older | 30ml, not more than 60ml in 24 hrs |
| children under 12 years of age | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient purified water, sodium hypochlorite
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses As a Laxative relieves occasional constipation (irregularity) usually produces bowel movement in ½ to 6 hours
Purpose
Information about the drug product’s indications for use.Purpose Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.milk of magnesia magnesium hydroxide MAGNESIUM HYDROXIDE MAGNESIUM CATION WATER opaque
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Delivers 30 mL NDC 69339-153-01 Milk of Magnesia, USP 2,400mg Magnesium Hydroxide/30mL Shake Well For Institutional Use Only 3 69339 15301 7 Lot# 123456 Exp: MM/YYYY DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 LD153.01.R0721 DASH-DOSE milk of magnesia image
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 201-786-6500 FOR INSTITUTIONAL USE ONLY DASH PHARMACEUTICALS Distributed by: Dash Pharmaceuticals LLC Upper Saddle RIver, NJ 07458
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied Milk of Magnesia, USP 2400mg/30ml is a white to offwhite liquid supplied as follows: NDC 69339-153-01 (1) unit dose cup 30ml NDC 69339-153-17 40 (4x10) unit dose cups 30ml NDC 69339-153-19 100 (10x10) unit dose cups 30ml
Storage and handling
Information about safe storage and handling of the drug product.Other information Each tablespoonful {15ml} contains: magnesium 500mg Sodium Content: not more than 324ppm Store at room temperature, 20-25°C (68-77°F). Avoid freezing. Original flavor sugar free, dye free, alcohol free, gluten free Do not use if lid seal is open or damaged See top of cup for lot number and expiration date
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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 (1-800-222-1222).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API