Milk Of Magnesia Concentrate

Milk Of Magnesia Concentrate
SPL v4
SPL
SPL Set ID 2a99a1a8-a830-429f-9cfd-3f29c3d3547c
Route
ORAL
Published
Effective Date 2022-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroxide Ion (2400 mg)
Inactive Ingredients
Hypromellose, Unspecified Trisodium Citrate Dihydrate Propylene Glycol Methylparaben Propylparaben Glycerin Sorbitol Solution Saccharin Sodium Sucrose Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-18

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 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9

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

As A Laxative
  • relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.
As An Antacid
  • heartburn
  • upset/sour stomach
  • acid indigestion
Other Information
  • each teaspoonful (5 mL) contains: magnesium 1000 mg
  • Sodium Content: 19 mg/10 mL
  • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
  • Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

dihydrate, sodium saccharin, sorbitol, and sucrose.

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 10 Ml)

Magnesium hydroxide 2400 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
Principal Display Panel 10 Ml Unit Dose Cup Tray Label

NDC 0121-0940-10

Milk of Magnesia Concentrate

Each 10 mL contains:

Magnesium Hydroxide 2400 mg.

ANTACID/ SALINE LAXATIVE

SHAKE WELL

Package Not Child-Resistant

See Insert


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 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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)
  • relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.
As An Antacid (As an Antacid)
  • heartburn
  • upset/sour stomach
  • acid indigestion
Other Information (Other information)
  • each teaspoonful (5 mL) contains: magnesium 1000 mg
  • Sodium Content: 19 mg/10 mL
  • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
  • Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients (Inactive ingredients)

glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

dihydrate, sodium saccharin, sorbitol, and sucrose.

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 10 Ml) (Active ingredient (in each 10 mL))

Magnesium hydroxide 2400 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
Principal Display Panel 10 Ml Unit Dose Cup Tray Label (PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label)

NDC 0121-0940-10

Milk of Magnesia Concentrate

Each 10 mL contains:

Magnesium Hydroxide 2400 mg.

ANTACID/ SALINE LAXATIVE

SHAKE WELL

Package Not Child-Resistant

See Insert


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)