MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid

MILK OF MAGNESIA ORIGINAL by

Drug Labeling and Warnings

MILK OF MAGNESIA ORIGINAL by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL cup)

Magnesium hydroxide 2400 mg

Purpose

Saline laxative

Uses

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

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.

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

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 – Tray

Original Flavor
Milk of Magnesia
(Magnesium Hydroxide)
Saline Laxative

FOR INSTITUTIONAL USE ONLY

Store at room temperature
and avoid freezing.

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

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA ORIGINAL 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60687-429(NDC:57896-649)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60687-429-76	10 in 1 CASE	02/18/2021
1	NDC: 60687-429-51	10 in 1 TRAY
1	NDC: 60687-429-45	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/18/2021

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(60687-429)