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

Purpose

Saline laxative

Description

Drug Facts


Medication Information

Purpose

Saline laxative

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.

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
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

Purpose

Saline laxative

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.

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.

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
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)