Label: MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 66689-053-99
- Packager: VistaPharm, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 11, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- Inactive Ingredients
-
FOR USE AS A LAXATIVE
INDICATIONS
Uses
- For relief of occasional constipation (irregularity)
- This product 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 more than 2 weeks
Ask a doctor or pharmacist before use if you are
- presently 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 (1-800-222-1222) right away.
DIRECTIONS
- shake well before use
- drink a full glass (8 oz) of liquid with each dose
- mL = milliliter
Adults and children
12 years of age and older
30 mL to 60 mL Children
6 to 11 years of age
15 mL to 30 mL Children
under 6 years of age
Consult a
physician.
or as directed by a physician.
- The dose may be taken as a single daily dose or in divided doses.
-
FOR USE AS AN ANTACID
INDICATIONS
Uses
For the relief of
- heartburn
- sour stomach
- acid indigestion
- and upset stomach associated with these symptoms
WARNINGS
Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician
May have laxative effect
Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug. Antacids may interact with certain prescription drugs.
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 (1-800-222-1222) right away.
DIRECTIONS
- shake well before use
- mL = milliliter
- adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician
- do not take more than 12 teaspoonfuls (60 mL) in 24-hour period
- do not use the maximum dosage for more than 2 weeks
- children under 12 years: consult a physician
- KEEP OUT OF REACH OF CHILDREN
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Cup Label
-
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-053 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66689-053-99 10 in 1 CASE 04/19/2018 1 10 in 1 TRAY 1 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 04/19/2018 Labeler - VistaPharm, Inc. (116743084)
