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| Product NDC Code | 55154-9403 | ||||
|---|---|---|---|---|---|
| Drug Name | Milk of magnesia |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 253017 | ||||
| Application Number | M001 | ||||
| Labeler Name | Cardinal Health 107, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL) Magnesium hydroxide 400 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 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 – 11 years 15 mL (1 TBSP) to 30 mL (2 TBSP) children under 6 years ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.
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 (usually within ½ to 6 hours) • occasional constipation (irregularity)
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 Milk of Magnesia MAGNESIUM HYDROXIDE HYDROXIDE ION HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POTASSIUM CITRATE PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL
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 Milk of Magnesia USP 5 Cups Bag 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 Distributed by: Cardinal Health Dublin, OH 43017 L33325170124
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.
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 400 mg • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing. • Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form: Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9403-5.
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 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