Label: MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 55154-4061-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 66689-053
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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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.
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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
-
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4061(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 HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color WHITE Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-4061-5 5 in 1 BAG 04/19/2018 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 Drug M001 04/19/2018 Labeler - Cardinal Health 107, LLC (118546603)
