FDA Label for Milk Of Magnesia
View Indications, Usage & Precautions
Milk Of Magnesia Product Label
The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
• relieves occasional constipation (irregularity)
• usually produces bowel movement in ½ hour to 6 hours
• 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 (8oz) of liquid with each dose
| age | dose |
| Adults and children over 12 years of age | Take 30mL (one unit dose) to 60mL (2 unit dose) |
| Children under 12 years of age | Ask a doctor |
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
FG-37/Iss.: 04/2023
Active Ingredient Per 30Ml (1 Unit Dose)
Magnesium hydroxide 2,400 mg
Purpose
Saline laxative
Otc - Ask Doctor
Ask a doctor before use if you have • Kidney disease • a magnesium-restricted diet • Stomach pain • a sudden change in bowel habits that lasts over 14 days
Otc - Ask Doctor/Pharmacist
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 may be signs of a serious condition
• you need to use a laxative for more than 1 week
Otc - Pregnancy Or Breast Feeding
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 accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Other Information
• each 30 mL (unit dose) contains Magnesium 1000 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• protect from freezing
• do not use if lid is torn or broken
Inactive Ingredient
Inactive ingredients purified water, and sodium hypochlorite.
NDC Information -
2400 mg/30 mL
Each 30 mL of Milk of Magnesia contains Magnesium hydroxide 2,400mg and is supplied in the following oral dosage forms:
NDC 57237-314-03 unit dose cup 30mL
NDC 57237-314-31 (100x30) unit dose cups 30mL
Otc - Questions
Questions or comments?Call 1-844-474-7464
Package Label.Principal Display Panel
2400 mg/30 mL
Lid Label NDC 57237-314-03
2400 mg/30 mL
Case Label NDC 57237-314-31
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