SPL v1
SPL
SPL Set ID ca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e
Route
ORAL
Published
Effective Date 2013-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (2400 mg)
Inactive Ingredients
Water Sodium Hypochlorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-12

Description

Active ingredient (in each 15 mL tablespoonful) Magnesium hydroxide 1200 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
Dosage and Administration

Directions

  • shake well before use
  • do not exceed the maximum recommended daily dose in a 24 hour period
  • 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



adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)

children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)

children under 6 years: ask a doctor

Description

Active ingredient (in each 15 mL tablespoonful) Magnesium hydroxide 1200 mg

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 50566-9
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
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 50569-3

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
Section 51727-6

Inactive ingredients

purified water, sodium hypochlorite

Section 51945-4





———PRINCIPAL DISPLAY PANEL———NDC: 24451-788-30

MILK OF MAGNESIA

DELIVERS 30 mL

CONTAINING:

MAGNESIUM HYDROXIDE

2400 mg

SALINE LAXATIVE

ORIGINAL FLAVOR

SUGAR FREE

SHAKE WELL

Exp: 00/00/00   Lot # 00000



Rpk By: Safecor Health LLC

Woburn, MA 01801

Dist. By: LLC Federal Solutions

Miami, FL 33132

Section 53414-9

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

Section 55105-1

Purpose

Saline laxative

Section 55106-9

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

Section 60561-8

Other information

  • each 15 mL tablespoonful contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use

Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
Dosage and Administration (34068-7)

Directions

  • shake well before use
  • do not exceed the maximum recommended daily dose in a 24 hour period
  • 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



adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)

children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)

children under 6 years: ask a doctor

Warnings and Precautions (34071-1)

Warnings

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 50566-9 (50566-9)
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
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 50569-3 (50569-3)

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
Section 51727-6 (51727-6)

Inactive ingredients

purified water, sodium hypochlorite

Section 51945-4 (51945-4)





———PRINCIPAL DISPLAY PANEL———NDC: 24451-788-30

MILK OF MAGNESIA

DELIVERS 30 mL

CONTAINING:

MAGNESIUM HYDROXIDE

2400 mg

SALINE LAXATIVE

ORIGINAL FLAVOR

SUGAR FREE

SHAKE WELL

Exp: 00/00/00   Lot # 00000



Rpk By: Safecor Health LLC

Woburn, MA 01801

Dist. By: LLC Federal Solutions

Miami, FL 33132

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Saline laxative

Section 55106-9 (55106-9)

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

Section 60561-8 (60561-8)

Other information

  • each 15 mL tablespoonful contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)