ca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e

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

Active Ingredient

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

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 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

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

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

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 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

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