OTC Medication Information: MILK OF MAGNESIA ORIGINAL

MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid
MAJOR Pharmaceuticals 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.

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

  • relieves occasional constipation (irregularity)
  • usually 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

‚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 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 older 30 mL to 60 mL
children 6 to 11 years 15 mL to 30 mL
children under 6 years ask a doctor

Other information

  • each 15 mL contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use

Inactive ingredients

purified water, sodium hypochlorite

Questions or comments?

800-616-2471

package Label

NDC 0904-0788-14
MAJOR

Milk of Magnesia

Saline Laxative

ORIGINAL FLAVOR
effective overnight relief

cramp free

stimulant free

sugar free

compare to the active ingredient of Phillips’ milk of magnesia

12 FL OZ (355 mL)

mom
(click image for full-size original)
MILK OF MAGNESIA ORIGINAL
magnesium hydroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-0788
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 1200 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYPOCHLORITE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-0788-14 355 mL in 1 BOTTLE None
2 NDC:0904-0788-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 12/08/2010
Labeler — MAJOR Pharmaceuticals Inc. (191427277)
Registrant — GCP Laboratories (965480861)
Establishment
Name Address ID/FEI Operations
GCP Laboratories 965480861 manufacture (0904-0788)

Revised: 11/2017 MAJOR Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.