Milk Of Magnesia Suspension
FDA Label NDC 57237-314

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Milk Of Magnesia (NDC 57237-314). 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 other, active ingredient per 30ml (1 unit dose), purpose, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

 agedose
Adults and children over 12 years of ageTake 30mL (one unit dose) to 60mL (2 unit dose)
Children under 12 years of ageAsk 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

Milk-of-mag-lid-lab-01 (Milk Of Mag Lid Lab 01)

Milk-of-mag-lid-lab-01 (Milk Of Mag Lid Lab 01)

2400 mg/30 mL

Case Label NDC 57237-314-31

Milk-of-mag-case-lab-01 (Milk Of Mag Case Lab 01)

Milk-of-mag-case-lab-01 (Milk Of Mag Case Lab 01)

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