FD mom mnt

FD mom mnt

Drug Labeling and Warnings

Drug Details

k">

MILK OF MAGNESIA- magnesium hydroxide suspension 
FAMILY DOLLAR SERVICES 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.

----------

FD mom mnt

Active ingredient (in each 15 mL)

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 older30 mL to 60 mL
children 6 to 11 years15 mL to 30 mL
children under 6 yearsask a doctor


Other information

  • each 15 mL contains: magnesium 500 mg
  • do not freeze
  • store at room temperature tightly closed

Inactive ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

Questions or comments?

1-800-540-3765

package Label

FAMILY WELLNESS

COMPARE TO THE ACTIVE
INGREDIENT IN PHILLIPS’®
MILK OF MAGNESIA*

Milk of Magnesia
MAGNESIUM HYDROXIDE
SALINE LAXATIVE
Cramp Free
Stimulant Free

MINT FLAVOR

12 FL OZ (355 mL)

GC

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-647
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-647-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/01/2017
Labeler - FAMILY DOLLAR SERVICES INC (024472631)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861pack(55319-647) , manufacture(55319-647)

Revised: 11/2017
 
FAMILY DOLLAR SERVICES INC


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.