MILK OF MAGNESIA- magnesium hydroxide suspension 
McKesson Corporation dba SKY Packaging

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Milk of Magnesia

Active ingredient(s)

Magnesium hydroxide 400mL

Purpose

Saline laxative

Use(s)

     As an antacid

  • heartburn
  • upset/sour stomach
  • acid indigestion

As a Laxative (usually within 1/2 to 6 hours)

  • occasional constipation (irregularity)

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

Pregnancy/Breastfeeding 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

As an Antacid

adults and children 12 years of age and over5 to 15 mL (1 to 3 teaspoonfuls)
children under 12 years of ageask a doctor

Laxative

adults and children 12 years and older30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 – 11 years15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 yearsask a doctor

Other information

NDC 63739-196-10:30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.

Questions

Call 1-800-845-8210

MANUFACTURED BY
Pharmaceutical
Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

NDC 63739-196-10

Milk of Magnesia USP
ANTACID, SALINE LAXATIVE

Each 30 mL contains:

Magnesium Hydroxide
2400 mg

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Package Not Child-Resistant

DISTRIBUTED BY

SKY Packaging

Memphis, TN 38141

NDC 63739-196-01

F0431C300923

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-196
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
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-196-1010 in 1 CASE01/29/2024
110 in 1 TRAY
1NDC:63739-196-0110 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 DrugM00701/29/2024
Labeler - McKesson Corporation dba SKY Packaging (140529962)
Registrant - PAI Holdings, LLC dba Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma044940096analysis(63739-196) , label(63739-196) , manufacture(63739-196) , pack(63739-196)

Revised: 2/2024
Document Id: c2eef76c-f868-4af6-9c1a-16544851de84
Set id: 978d7aa4-24aa-4fac-91af-6d6f228fefaf
Version: 5
Effective Time: 20240207
 
McKesson Corporation dba SKY Packaging