Milk Of Magnesia

Milk Of Magnesia
SPL v1
SPL
SPL Set ID 3f7cff50-749b-5275-e063-6394a90af407
Route
ORAL
Published
Effective Date 2022-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroxide Ion (400 mg)
Inactive Ingredients
Silica Methylparaben Glycerin Propylene Glycol Water Sucralose Propylparaben Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 1979-09-04

Description

Drug Facts

Purpose

Saline laxative


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Purpose

Saline laxative

Dosage and Administration

Directions

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
Age Dose
adults and children 12 years and older 30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years of age 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 20°C to 25°C (68°F to 77°F).
  • Avoid freezing
  • Protect from light
  • Milk of Magnesia, USP is a milky-white cherry flavored suspension supplied in the following oral dosage forms:

NDC 81033-014-30: 30 mL unit-dose cup

NDC 81033-014-52: Case containing 100 unit-dose cups of 30 mL each.

Inactive Ingredients

cherry flavor, fumed silica, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

Call 1-833-537-4679

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 81033-014-52

Milk of Magnesia, USP 2400 mg per 30 mL

Delivers 30 mL

Case = 100 UD Cups


Structured Label Content

Indications and Usage (34067-9)

Uses

Dosage and Administration (34068-7)

Directions

Warnings and Precautions (34071-1)

Warnings

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
Age Dose
adults and children 12 years and older 30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years of age 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 20°C to 25°C (68°F to 77°F).
  • Avoid freezing
  • Protect from light
  • Milk of Magnesia, USP is a milky-white cherry flavored suspension supplied in the following oral dosage forms:

NDC 81033-014-30: 30 mL unit-dose cup

NDC 81033-014-52: Case containing 100 unit-dose cups of 30 mL each.

Inactive Ingredients (Inactive ingredients)

cherry flavor, fumed silica, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-833-537-4679

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 81033-014-52

Milk of Magnesia, USP 2400 mg per 30 mL

Delivers 30 mL

Case = 100 UD Cups


Advanced Ingredient Data


Raw Label Data

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