Milk Of Magnesia

Milk Of Magnesia
SPL v9
SPL
SPL Set ID 978d7aa4-24aa-4fac-91af-6d6f228fefaf
Route
ORAL
Published
Effective Date 2024-01-01
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 Water Cyclomethicone 4 Propylparaben Sorbitol Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-01-01 Until 2026-07-31

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:
NDC 63739-196.01 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.
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

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)
Principal Display Panel 30 Ml Cup Tray Label

NDC 63739-196-01

Milk of Magnesia USP

ANTACID, SALINE LAXATIVE

Each 30 mL contains:

Magnesium Hydroxide

2400 mg

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

  Memphis, TN 38141       

                                                   


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:
NDC 63739-196.01 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.
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

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

NDC 63739-196-01

Milk of Magnesia USP

ANTACID, SALINE LAXATIVE

Each 30 mL contains:

Magnesium Hydroxide

2400 mg

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

  Memphis, TN 38141       

                                                   


Advanced Ingredient Data


Raw Label Data

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