MILK OF MAGNESIA- magnesium hydroxide suspension 
Chain Drug Consortium, LLC

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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pv mom

Active ingredient (in each 15 mL tablespoonful))

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

  • relieves occasional constipation (irregularity)
  • 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 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 older2 - 4 tablespoons (TBSP)
children 6 to 11 years1 - 2 tablespoons (TBSP
children under 6 yearsask a doctor

Other information

  • each 15 mL tablespoonful contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use
  • TAMPER-EVIDENT: Do not use if imprinted neckband

is missing or broken.

Inactive ingredients

purified water, sodium hypochlorite

Questions or comments?

1-800-540-3765

package Label

pv

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-469
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-469-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/201209/01/2022
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(68016-469) , pack(68016-469)

Revised: 12/2021
 
Chain Drug Consortium, LLC