Active Ingredient (In Each 15 Ml Tablespoonful)
Magnesium hydroxide 1200 mg
Milk Of Magnesia Suspension
FDA Label NDC 80447-649
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fact Products for the product Milk Of Magnesia (NDC 80447-649). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 15 ml tablespoonful), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 1/2 to 6 hours
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away.
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
| age | dose |
| adults and children 12 years and over | 30 mL to 60 mL |
| children 6 to 11 years | 15 mL to 30 mL |
| children under 6 years | ask a doctor |
Other Information
• each 15 mL tablespoonful contains: magnesium 500 mg
• avoid freezing
• store at room temperature tightly closed
Inactive Ingredients
purified water, sodium hypochlorite
Questions Or Comments?
1-800-540-3765
Package Label
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