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NDC 60687-0429-76 MILK OF MAGNESIA ORIGINAL 1200 mg/15mL Details

MILK OF MAGNESIA ORIGINAL 1200 mg/15mL

MILK OF MAGNESIA ORIGINAL is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by American Health Packaging. The primary component is MAGNESIUM HYDROXIDE.

MedlinePlus Drug Summary

Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.

Related Packages: 60687-0429-76
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Magnesium Hydroxide

Product Information

NDC	60687-0429
Product ID	60687-429_ad531eda-e838-8769-e053-2a95a90ad41f
Associated GPIs	46100010101820
GCN Sequence Number	003026
GCN Sequence Number Description	magnesium hydroxide ORAL SUSP 400 MG/5ML ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	07950
HICL Sequence Number	001329
HICL Sequence Number Description	MAGNESIUM HYDROXIDE
Brand/Generic	Generic
Proprietary Name	MILK OF MAGNESIA ORIGINAL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Magnesium Hydroxide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/15mL
Substance Name	MAGNESIUM HYDROXIDE
Labeler Name	American Health Packaging
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60687-0429-76 (60687042976)

Pricing Information	N/A
NDC Package Code	60687-429-76
Billing NDC	60687042976
Package	10 TRAY in 1 CASE (60687-429-76) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-429-51) / 30 mL in 1 CUP, UNIT-DOSE (60687-429-45)
Marketing Start Date	2020-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7d7d789b-b2e7-4600-a025-0cd2ff5b3672 Details

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60687-429-76	10 in 1 CASE	09/01/2020
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/01/2020

Labeler - American Health Packaging (929561009)

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

Revised: 8/2020

Document Id: ad531eda-e838-8769-e053-2a95a90ad41f

Set id: 7d7d789b-b2e7-4600-a025-0cd2ff5b3672

Version: 1

Effective Time: 20200820