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| Product NDC Code | 60687-429 | ||||
|---|---|---|---|---|---|
| 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 | ||||
| RxCUI drug identifier | 253017 | ||||
| Application Number | M007 | ||||
| Labeler Name | American Health Packaging | ||||
| Packages |
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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, 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 1 unit dose cup (30 mL) to 2 unit dose cups (60 mL) children 6 to 11 years ½ unit dose cup (15 mL) to 1 unit dose cup (30 mL) 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) usually 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 WATER SODIUM HYPOCHLORITE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION
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 – Tray Original Flavor Milk of Magnesia (Magnesium Hydroxide) Saline Laxative FOR INSTITUTIONAL USE ONLY Store at room temperature and avoid freezing. 8442972/0920F Tray Label
Principal Display Panel – Cup NDC 60687- 429 -45 Original Flavor Milk of Magnesia (Magnesium Hydroxide) Saline Laxative 2400 mg/30 mL Delivers 30 mL SHAKE WELL. AVOID FREEZING. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only American Health Packaging Columbus, OH 43217 0442972/0320 Cup Label 2400 mg/30 mL
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.PACKAGING INFORMATION American Health Packaging unit dose cups (see Other Information section) contain drug product from Geri-Care Pharmaceuticals as follows: (2400 mg per 30 mL / 100 UD) NDC 60687-429-76 packaged from NDC 57896-649 Distributed by: American Health Packaging Columbus, OH 43217 8442972/0920F
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 30 mL cup contains: magnesium 1000 mg store at room temperature and avoid freezing DO NOT USE IF SEAL IS BROKEN This drug product is supplied in 30 ml unit dose cups as: 100 cups (10 x 10) ND 60687-429-76
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