MILK OF MAGNESIA- magnesium hydroxide suspension 
VistaPharm, Inc.

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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Milk of Magnesia

saline laxative/antacid

DESCRIPTION

Active Ingredient

(in each 5 mL = 1 teaspoonful)

Magnesium Hydroxide.................400 mg

Inactive Ingredients

anhydrous citric acid, benzyl alcohol, methylparaben, propylene glycol, propylparaben, purified water.

FOR USE AS A LAXATIVE

INDICATIONS

Uses

  • For relief of occasional constipation (irregularity)
  • This product generally 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 more than 2 weeks

Ask a doctor or pharmacist before use if you are

  • presently 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 (1-800-222-1222) right away.

DIRECTIONS

  • shake well before use
  • drink a full glass (8 oz) of liquid with each dose
  • mL = milliliter

Adults and children

12 years of age and older

30 mL to 60 mL

Children

6 to 11 years of age

15 mL to 30 mL

Children

under 6 years of age

Consult a

physician.

or as directed by a physician.

  • The dose may be taken as a single daily dose or in divided doses.

FOR USE AS AN ANTACID

INDICATIONS

Uses

For the relief of

  • heartburn
  • sour stomach
  • acid indigestion
  • and upset stomach associated with these symptoms

WARNINGS

Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician

May have laxative effect

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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 (1-800-222-1222) right away.

DIRECTIONS

  • shake well before use
  • mL = milliliter
  • adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician
  • do not take more than 12 teaspoonfuls (60 mL) in 24-hour period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years: consult a physician

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

HOW SUPPLIED

Milk of Magnesia USP 400 mg/5 mL is a white opaque liquid supplied as follows:

NDC 66689-053-01: 30 mL unit-dose cup

NCD 66689-053-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-053-01), packaged in 10 trays of 10 unit-dose cups each.

STORAGE

Other Information

  • Protect from freezing
  • Store at 20° to 25°C (68° to 77°F)

Questions or Comments?

Call 1-888-655-1505 (toll-free)

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

VP2152R1

09/17

PRINCIPAL DISPLAY PANEL - 30 mL Cup Label

Milk of Magnesia,  USP

2,400 mg Magnesium Hydroxide per 30 mL

Delivers 30 mL

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F).

Shake Well

XACTDOSETM

Manufactured by:
VistaPharm, Inc.
Largo, FL 33771, USA

VP2153R2

01/18

NDC 66689-053-01

lidding-label
Lidding-Label
MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66689-053
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66689-053-9910 in 1 CASE04/19/2018
110 in 1 TRAY
130 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33104/19/2018
Labeler - VistaPharm, Inc. (116743084)

Revised: 11/2020
Document Id: 774c9bcf-e112-42d3-a5e0-2f23173cf6ed
Set id: 61e230d7-2848-4f08-b258-1de584720200
Version: 4
Effective Time: 20201111
 
VistaPharm, Inc.