Active Ingredient (In Each 30 Ml Dose)
Magnesium hydroxide 2400 mg
Milk Of Magnesia Suspension
FDA Label NDC 0121-0431
15 label sections · Submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Milk Of Magnesia (NDC 0121-0431). 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 30 ml dose), purpose, uses as antacid, uses as saline laxative, ask a doctor before use if you have, when using this product, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid / Saline Laxative
Uses As Antacid
• relieves
• heartburn
• sour stomach
• acid indigestion
• and upset stomach associated with these symptoms
Uses As Saline Laxative
• for relief of occasional constipation (irregularity)
• this product generally produces bowel movement in 1/2 to 6 hours
Ask A Doctor Before Use If You Have
- kidney disease
- a magnesium-restricted diet
• kidney disease
• a magnesium-restricted diet
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
• do not take more than 60 mL (2 doses) in a 24-hour period
• do not use the maximum dosage for more than 2 weeks except under the advice and superision of a doctor
• may cause a laxative effect
Ask A Doctor Or Pharmacist Before Use If You Are
• presently 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 that 1 week
Directions For Antacid
• shake well before use
• mL=milliliters
• adults and children 12 years of age or older: 30 mL (1 dose) up to 2 times a day or as directed by a doctor
• children under 12 years of age: ask a doctor
Directions For Saline Laxative
• do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
• shake well before use
• mL=milliliters
• drink a full glass (8 oz) of liquid with each dose
• adults and children 12 years of age or older: 30 mL to 60 mL (1 to 2 doses)
• children under 12 years of age: ask a doctor
• the dose may be taken as a single daily dose or in divided doses
Other Information For Antacid
• each 30 mL contains: magnesium 1 g
• store at 20-25°C (68-77°F)
• protect from freezing
• tamper-evident: do not use if seal on cup is missing or torn
Other Information For Saline Laxative
• each 30 mL contains: magnesium 1 g
• store at 20-25°C (68-77°F)
• protect from freezing
• tamper-evident: do not use if seal on cup is missing or torn
Inactive Ingregients
Inactive ingredients antifoam af emulsion, flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sodium saccharin, sorbitol
Questions Or Comments?
Questions or comments? call 1-800-845-8210
Principal Display Panel - 30 Ml Cup Tray Label
Delivers 30 mL
NDC 0121-0431-30
Milk of Magnesia USP
Magnesium Hydroxide 2400 mg
Antacid / Saline Laxative
SHAKE WELL
Package Not Child-Resistant
Dist. by: PAI Parma
Greenville, SC 29605
SEE DRUG FACTS INSERT
F0431300924
Lidding For 30 mL Cup (M O M 1)
* Please review the disclaimer below.
