Label: MILK OF MAGNESIA- magnesium hydroxide suspension
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- NDC Code(s): 55154-4160-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-6846
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 31, 2022
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Purpose
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Dosage and Administration
Directions
Age (yr)
Dose (mL)
adults and children 12 years and over
30 mL, not more than 60 mL in 24 hrs.
children under 12 years
ask a doctor
- do not exceed the maximum recommended daily dose in a 24 hour period
- shake well before use
- dose may be taken once a day preferably at bedtime, or as directed by a doctor
- drink a full glass (8 oz) of liquid with each dose
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Indications and Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in ½ 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 taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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Stop use and ask a doctor if
- you have rectal bleeding or no bowel movements after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
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If pregnant or breast-feeding, ask a health professional before use.
- Storage and Handling
- Keep Out of Reach of Children
- Inactive Ingredients
- Milk of Magnesia 2400 mg / 30 mL
- Milk of Magnesia 2400 mg / 30 mL
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4160(NDC:0904-6846) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 2400 mg in 30 mL Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8) SUCRALOSE (UNII: 96K6UQ3ZD4) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (Suspension) Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-4160-5 5 in 1 BAG 05/12/2022 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 06/10/2019 Labeler - Cardinal Health 107, LLC (118546603)
