MILK OF MAGNESIA- magnesium hydroxide suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)
Available from:
KROGER COMPANY
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Saline laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in ½ to 6 hours
Authorization status:
OTC monograph not final
Authorization number:
30142-547-12

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MILK OF MAGNESIA- magnesium hydroxide suspension

KROGER COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KRO mom mnt

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

Purpos e

Saline laxative

Us es

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 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

dose

adults and children 12

years and over

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: magnesium 500 mg

avoid freezing

store at room temperature tightly closed

Inactive ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

Questions or comments?

1-800-632-6900

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MILK OF MAGNESIA

magnesium hydroxide suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-547

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

MAGNESIUM HYDRO XIDE (UNII: NBZ3QY0 0 4S) (MAGNESIUM CATION - UNII:T6 V3LHY8 38 ,

HYDROXIDE ION - UNII:9 159 UV38 1P)

MAGNESIUM

HYDROXIDE

120 0 mg

in 15 mL

KROGER COMPANY

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM HYPO CHLO RITE (UNII: DY38 VHM5OD)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Product Characteristics

Color

white (o paque)

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-547-12

355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 3/0 1/20 20

Labeler -

KROGER COMPANY (006999528)

Registrant -

GCP Laboratories (965480861)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GCP Labo rato ries

9 6 548 0 8 6 1

ma nufa c ture (30 142-547)

Revised: 11/2020

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