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

Purpose

Saline laxative

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Purpose

Saline laxative

Dosage and Administration

Directions

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

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
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

Warnings and Precautions (34071-1)

Warnings

Indications and Usage (34067-9)

Uses

Purpose

Saline laxative

Dosage and Administration (34068-7)

Directions

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

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.

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
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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