MILK OF MAGNESIA MINT: Package Insert and Label Information

MILK OF MAGNESIA MINT- magnesium hydroxide liquid
Geri-Care Pharmaceuticals, Corp

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 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

‚Äč 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 2 to 4 tablespoonfuls
children 6 to 11 years 1 to 2 tablespoonfuls
children under 6 years ask a doctor

Other information

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

Inactive ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

package Label

1
(click image for full-size original)

MILK OF MAGNESIA MINT
magnesium hydroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-647
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
SACCHARIN SODIUM (SACCHARIN)
Product Characteristics
Color Score
Shape Size
Flavor MINT (mint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-647-12 355 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 01/01/2000
Labeler — Geri-Care Pharmaceuticals, Corp (611196254)
Registrant — GCP Laboratories (965480861)
Establishment
Name Address ID/FEI Operations
GCP Laboratories 965480861 manufacture (57896-647)

Revised: 03/2023 Geri-Care Pharmaceuticals, Corp

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