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| Product NDC Code | 17856-0788 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Milk of magnesia original |
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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 | LIQUID | ||||||
| Application Number | M007 | ||||||
| Labeler Name | ATLANTIC BIOLOGICALS CORP. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 15 mL) Magnesium hydroxide 1200 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, in divided doses, or as directed by a doctor • drink a full glass (8 oz) of liquid with each dose adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP) children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP) children under 6 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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 relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 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 ORIGINAL magnesium hydroxide MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION WATER SODIUM HYPOCHLORITE
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.MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID image 1
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.In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
Storage and handling
Information about safe storage and handling of the drug product.Other information • magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use • each 15 mL tablespoonful contains: TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
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 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 b efore use. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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