Milk Of Magnesia

SPL v1

SPL

SPL Set ID c3d14605-fdec-49fc-b0ee-d4c3ae5f42b5

Route

ORAL

Published

Effective Date 2026-01-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydroxide Ion (2400 mg)

Inactive Ingredients

Cyclomethicone 4 Hypromellose 2910 (4000 Mpa.s) Methylparaben Potassium Citrate Propylene Glycol Propylparaben Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-08

Description

Drug Facts

Purpose

Antacid / Saline Laxative

Medication Information

Purpose

Antacid / Saline Laxative

Description

Drug Facts

Uses

• relieves

• heartburn

• sour stomach

• acid indigestion

• and upset stomach associated with these symptoms

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Section 50568-5

Ask a doctor or pharmacist before use If you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 51727-6

Inactive ingredients antifoam af emulsion, flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sodium saccharin, sorbitol

Section 53413-1

Questions or comments? call 1-800-845-8210

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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

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

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 seriouscondition.

• you need to use a laxative for more that 1 week

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

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

Ask A Doctor Before Use If You Have

• kidney disease

• a magnesium-restricted diet

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

Active Ingredient (in Each 30 Ml Dose)

Magnesium hydroxide 2400 mg

Principal Display Panel 30 Ml Cup Tray Label

MAJOR^®

NDC 0904-7564-62

Milk of Magnesia USP

Magnesium Hydroxide 2400 mg

Antacid / Saline Laxative

2400 mg/ 30 mL

SHAKE WELL

Delivers 30 mL

See Drugs Facts Insert

For Institutional Use Only

MAJOR^® PHARMACEUTICALS

Indianapolis, IN 46268

F0431C300325

Ask A Doctor Or Pharmacist Before Use If You Are

• presently taking a prescription drug. This product may interact with certain prescription drugs.

Structured Label Content

Uses

• relieves

• heartburn

• sour stomach

• acid indigestion

• and upset stomach associated with these symptoms

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use If you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 51727-6 (51727-6)

Inactive ingredients antifoam af emulsion, flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sodium saccharin, sorbitol

Section 53413-1 (53413-1)

Questions or comments? call 1-800-845-8210

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid / Saline Laxative

Directions for Antacid

When Using This Product (When using this product)

Stop Use and Ask A Doctor If (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 seriouscondition.

• you need to use a laxative for more that 1 week

Other Information for Antacid (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

Directions for Saline Laxative

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• kidney disease

• a magnesium-restricted diet

Other Information for Saline Laxative (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

Active Ingredient (in Each 30 Ml Dose) (Active ingredient (in each 30 mL dose))

Magnesium hydroxide 2400 mg

Principal Display Panel 30 Ml Cup Tray Label (PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label)

MAJOR^®

NDC 0904-7564-62

Milk of Magnesia USP

Magnesium Hydroxide 2400 mg

Antacid / Saline Laxative

2400 mg/ 30 mL

SHAKE WELL

Delivers 30 mL

See Drugs Facts Insert

For Institutional Use Only

MAJOR^® PHARMACEUTICALS

Indianapolis, IN 46268

F0431C300325

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use If you are)

• presently taking a prescription drug. This product may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "2400", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CYCLOMETHICONE 4", "unii": "CZ227117JE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (4000 MPA.S)", "unii": "RN3152OP35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CITRATE", "unii": "EE90ONI6FF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• relieves • heartburn • sour stomach • acid indigestion • and upset stomach associated with these symptoms", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.", "50568-5": "Ask a doctor or pharmacist before use If you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.", "51727-6": "Inactive ingredients antifoam af emulsion, flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sodium saccharin, sorbitol", "53413-1": "Questions or comments? call 1-800-845-8210", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antacid / Saline Laxative", "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", "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", "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 seriouscondition. • you need to use a laxative for more that 1 week", "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", "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", "Ask a doctor before use if you have": "• kidney disease • a magnesium-restricted diet", "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", "Active ingredient (in each 30 mL dose)": "Magnesium hydroxide 2400 mg", "PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label": "MAJOR ® NDC 0904-7564-62 Milk of Magnesia USP Magnesium Hydroxide 2400 mg Antacid / Saline Laxative 2400 mg/ 30 mL SHAKE WELL Delivers 30 mL See Drugs Facts Insert For Institutional Use Only MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 F0431C300325", "Ask a doctor or pharmacist before use If you are": "• presently taking a prescription drug. This product may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.899488 · Updated: 2026-03-14T23:12:18.638181