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NDC 70000-0027-01 leader milk of magnesia 1200 mg/15mL Details

leader milk of magnesia 1200 mg/15mL

leader milk of magnesia is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0027-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Magnesium Hydroxide

Product Information

NDC	70000-0027
Product ID	70000-0027_05dcd345-846d-42b8-b098-4f0a3f5e15ba
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	leader milk of magnesia
Proprietary Name Suffix	n/a
Non-Proprietary Name	Magnesium hydroxide
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/15mL
Substance Name	MAGNESIUM HYDROXIDE
Labeler Name	Cardinal Health 110, LLC. dba Leader
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 70000-0027-01 (70000002701)

Pricing Information	N/A
NDC Package Code	70000-0027-1
Billing NDC	70000002701
Package	355 mL in 1 BOTTLE (70000-0027-1)
Marketing Start Date	2020-01-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 85704f8c-0521-44ce-84a9-565c140764d0 Details

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

•: relieves occasional constipation (irregularity)
•: generally produces bowel movement in ½ 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 more than 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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 (1-800-222-1222).

Directions

•: do not exceed the maximum recommended daily dose in a 24 hour period
•: shake well before use
•: 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
•: for accurate dosing, use dose cup provided
•: mL = milliliter

adults and children 12 years and older	30 mL to 60 mL
children 6 to 11 years	15 mL to 30 mL
children under 6 years	ask a doctor

Other information

•: each 15 mL contains: calcium 20 mg and magnesium 595 mg
•: does not meet USP requirements for preservative effectiveness
•: store at 20°-25°C (68°-77°F)
•: close cap tightly after use
•: avoid freezing

Inactive ingredient

purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Genuine

Milk of Magnesia

Magnesium Hydroxide, 1200 mg per 15 mL

Saline Laxative

Original Flavor

Stimulant-Free

Comfortable, Cramp-Free Relief

Sugar-Free

COMPARE TO PHILLIP’S® MILK OF MAGNESIA active ingredient

100% Money Back Guarantee

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

LEADER MILK OF MAGNESIA

magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0027
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)

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0027-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/29/2020

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021

Document Id: 05dcd345-846d-42b8-b098-4f0a3f5e15ba

Set id: 85704f8c-0521-44ce-84a9-565c140764d0

Version: 2

Effective Time: 20210618