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

​ 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

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