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| Product NDC Code | 0121-0940 | ||||
|---|---|---|---|---|---|
| Drug Name | Milk of magnesia concentrate |
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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 | 314087 | ||||
| Application Number | M007 | ||||
| Labeler Name | PAI Holdings, 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 10 mL) 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 As an Antacid do not exceed the maximum recommended daily dose of 20 mL 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 mL (1 teaspoonful) children under 12 years of age ask a doctor As a Laxative do not exceed the maximum recommended daily dose 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 adults and children 12 years and older 15 mL to 30 mL children under 12 years ask a doctor
| adults and children 12 years of age and over | 5 mL (1 teaspoonful) |
| children under 12 years of age | ask a doctor |
| adults and children 12 years and older | 15 mL to 30 mL |
| children under 12 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sodium saccharin, sorbitol, and sucrose.
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 an Antacid heartburn upset/sour stomach acid indigestion As a Laxative relieves occasional constipation (irregularity) This product 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 Concentrate MAGNESIUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION HYPROMELLOSE, UNSPECIFIED TRISODIUM CITRATE DIHYDRATE PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN GLYCERIN SORBITOL SOLUTION SACCHARIN SODIUM SUCROSE WATER LEMON-0IL
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 - 10 mL Unit-Dose Cup Tray Label NDC 0121-0940-10 Milk of Magnesia Concentrate Each 10 mL contains: Magnesium Hydroxide 2400 mg. ANTACID/ SALINE LAXATIVE SHAKE WELL Package Not Child-Resistant See Insert PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R07/21
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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.
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? Call 1-800-845-8210
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information each teaspoonful (5 mL) contains: magnesium 1000 mg Sodium Content: 19 mg/10 mL store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing. Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form: NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.
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.
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