Original Flavor Milk Of Magnesia

Original Flavor Milk Of Magnesia
SPL v2
SPL
SPL Set ID 7d7d789b-b2e7-4600-a025-0cd2ff5b3672
Route
ORAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroxide Ion (1200 mg)
Inactive Ingredients
Water Sodium Hypochlorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-18

Description

Magnesium hydroxide 2400 mg

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

Magnesium hydroxide 2400 mg

Uses
  • relieves occasional constipation (irregularity)
  • usually produces bowel movement in 1/2 to 6 hours
Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug.

This product may interact with certain prescription drugs.

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

If pregnant or breast-feeding,

ask a health professional before use.

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

1 unit dose cup (30 mL) to 2 unit dose cups (60 mL)

children 6 to 11 years

½ unit dose cup (15 mL) to 1 unit dose cup (30 mL)

children under 6 years

ask a doctor

Other Information
  • each 30 mL cup contains: magnesium 1000 mg
  • store at room temperature and avoid freezing
  • DO NOT USE IF SEAL IS BROKEN
  • This drug product is supplied in 30 ml unit dose cups as:

    100 cups (10 x 10) ND 60687-429-76
Inactive Ingredients

purified water, sodium hypochlorite

Packaging Information

American Health Packaging unit dose cups (see Other Information section) contain drug product from Geri-Care Pharmaceuticals as follows:

(2400 mg per 30 mL / 100 UD) NDC 60687-429-76 packaged from NDC 57896-649

Distributed by:

American Health Packaging

Columbus, OH 43217

8442972/0920F

Principal Display Panel – Cup

NDC 60687- 429-45

Original Flavor

Milk of Magnesia

(Magnesium Hydroxide)

Saline Laxative

2400 mg/30 mL

Delivers 30 mL

SHAKE WELL. AVOID FREEZING.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only

American Health Packaging

Columbus, OH 43217

0442972/0320

Principal Display Panel – Tray

Original Flavor

Milk of Magnesia

(Magnesium Hydroxide)

Saline Laxative

FOR INSTITUTIONAL USE ONLY

Store at room temperature

and avoid freezing.

8442972/0920F

Active Ingredient (in Each 30 Ml Cup)

Magnesium hydroxide 2400 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • usually produces bowel movement in 1/2 to 6 hours
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.

Purpose

Saline laxative

Warnings

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug.

This product may interact with certain prescription drugs.

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

If pregnant or breast-feeding,

ask a health professional before use.

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

1 unit dose cup (30 mL) to 2 unit dose cups (60 mL)

children 6 to 11 years

½ unit dose cup (15 mL) to 1 unit dose cup (30 mL)

children under 6 years

ask a doctor

Other Information (Other information)
  • each 30 mL cup contains: magnesium 1000 mg
  • store at room temperature and avoid freezing
  • DO NOT USE IF SEAL IS BROKEN
  • This drug product is supplied in 30 ml unit dose cups as:

    100 cups (10 x 10) ND 60687-429-76
Inactive Ingredients (Inactive ingredients)

purified water, sodium hypochlorite

Packaging Information (PACKAGING INFORMATION)

American Health Packaging unit dose cups (see Other Information section) contain drug product from Geri-Care Pharmaceuticals as follows:

(2400 mg per 30 mL / 100 UD) NDC 60687-429-76 packaged from NDC 57896-649

Distributed by:

American Health Packaging

Columbus, OH 43217

8442972/0920F

Principal Display Panel – Cup

NDC 60687- 429-45

Original Flavor

Milk of Magnesia

(Magnesium Hydroxide)

Saline Laxative

2400 mg/30 mL

Delivers 30 mL

SHAKE WELL. AVOID FREEZING.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only

American Health Packaging

Columbus, OH 43217

0442972/0320

Principal Display Panel – Tray

Original Flavor

Milk of Magnesia

(Magnesium Hydroxide)

Saline Laxative

FOR INSTITUTIONAL USE ONLY

Store at room temperature

and avoid freezing.

8442972/0920F

Active Ingredient (in Each 30 Ml Cup) (Active ingredient (in each 30 mL cup))

Magnesium hydroxide 2400 mg


Advanced Ingredient Data


Raw Label Data

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