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MILK OF MAGNESIA by FREDS, INC

Dosage form: suspension
Ingredients: MAGNESIUM HYDROXIDE 1200mg in 15mL
Labeler: FREDS, INC
NDC Code: 55315-649

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.

freds mom

Active ingredient (in each tablespoon = TBSP)

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 2 weeks

‚Äč 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 this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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
  • follow each dosage with a full glass (8oz) of fluid
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 tablespoon contains: magnesium 500 mg
  • do not freeze
  • store at room temperature tightly closed

Inactive ingredients

purified water, sodium hypochlorite

package Label

FREDS

Milk Of
Magnesia

Saline Laxative

• Gentle Dependable Overnight Relief
• Sugar Free • Cramp Free
• Stimulant Free
Original
Tested Against The Active Ingredient In:
Phillips® Milk of
Magnesia*

12 FL OZ (355 mL)

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-649
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM HYPOCHLORITE 
Packaging
#Item CodePackage Description
1NDC:55315-649-12355 mL in 1 BOTTLE
2NDC:55315-649-26769 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2012
Labeler - FREDS, INC (005866116)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(55315-649), pack(55315-649)

Revised: 12/2017
 
FREDS, INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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