Milk Of Magnesia

SPL v13

SPL

SPL Set ID 144c7242-4ff9-404a-86bf-48e2871eb0cd

Route

ORAL

Published

Effective Date 2025-04-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydroxide Ion (400 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-06-07

Description

Drug Facts

Purpose

Saline laxative

Medication Information

Purpose

Saline laxative

Description

Drug Facts

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

Section 53414-9

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

As A Laxative

•
do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
•
shake well before use
•
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.
•
mL = milliliter; TBSP = Tablespoon

adults and children 12 years and older	30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 – 11 years	15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 years	ask a doctor

As An Antacid

•
heartburn
•
upset/sour stomach
•
acid indigestion

Other Information

•
each teaspoonful (5 mL) contains:magnesium 400 mg
•
store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
•
Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:

Inactive Ingredients

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

Questions Or Comments?

Call 1-800-845-8210

Principal Display Panel

NDC 55154-9403-5

MILK OF MAGNESIA USP

5 CUPS

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

Active Ingredient (in Each 5 Ml)

Magnesium hydroxide 400 mg

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

As A Laxative (usually Within ½ to 6 Hours)

•
occasional constipation (irregularity)

Overbagged With 5 X 30 Ml Unit Dose Cups in Each Bag, Ndc 55154 9403 5

See product insert for prescribing information, precautions and warnings.

PROTECT FROM FREEZING.

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Structured Label Content

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

Section 53414-9 (53414-9)

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

Purpose

Saline laxative

As A Laxative (As a Laxative)

•
do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
•
shake well before use
•
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.
•
mL = milliliter; TBSP = Tablespoon

adults and children 12 years and older	30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 – 11 years	15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 years	ask a doctor

As An Antacid (As an Antacid)

•
heartburn
•
upset/sour stomach
•
acid indigestion

Other Information (Other information)

•
each teaspoonful (5 mL) contains:magnesium 400 mg
•
store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
•
Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210

Principal Display Panel

NDC 55154-9403-5

MILK OF MAGNESIA USP

5 CUPS

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 serious condition.
•
you need to use a laxative for more than 1 week

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Magnesium hydroxide 400 mg

Ask A Doctor Before Use If You Have (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

As A Laxative (usually Within ½ to 6 Hours) (As a Laxative (usually within ½ to 6 hours))

•
occasional constipation (irregularity)

Overbagged With 5 X 30 Ml Unit Dose Cups in Each Bag, Ndc 55154 9403 5 (Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9403-5)

See product insert for prescribing information, precautions and warnings.

PROTECT FROM FREEZING.

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Advanced Ingredient Data

[{"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": "CYCLOMETHICONE 4", "unii": "CZ227117JE", "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)

{"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 taking a prescription drug. This product may interact with certain prescription drugs.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Saline laxative", "As a Laxative": "• do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period • shake well before use • 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. • mL = milliliter; TBSP = Tablespoon adults and children 12 years and older 30 mL (2 TBSP) to 60 mL (4 TBSP) children 6 – 11 years 15 mL (1 TBSP) to 30 mL (2 TBSP) children under 6 years ask a doctor", "As an Antacid": "• heartburn • upset/sour stomach • acid indigestion", "Other information": "• each teaspoonful (5 mL) contains: magnesium 400 mg • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing. • Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:", "Inactive ingredients": "flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.", "Questions or comments?": "Call 1-800-845-8210", "Principal Display Panel": "NDC 55154-9403-5 MILK OF MAGNESIA USP 5 CUPS", "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", "Active ingredient (in each 5 mL)": "Magnesium hydroxide 400 mg", "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", "As a Laxative (usually within ½ to 6 hours)": "• occasional constipation (irregularity)", "Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9403-5": "See product insert for prescribing information, precautions and warnings. PROTECT FROM FREEZING. WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:03.358544 · Updated: 2026-03-14T23:08:35.242045