Label: LEADER MILK OF MAGNESIA- magnesium hydroxide liquid
- NDC Code(s): 37205-459-40
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 15 mL TBSP)
Magnesium hydroxide 1200 mgClose
- relieves occasional constipation (irregularity)
- generally produces bowel movement in ½ to 6 hours
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.
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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
- for accurate dosing, use dose cup provided
- TBSP = tablespoonful
adults and children 12 years and older
2 to 4 TBSP.
children 6 to 11 years
1 to 2 TBSP.
children under 6 years
ask a doctor
- Other information
- each tablespoon (15 mL) contains: calcium 20 mg, magnesium 595 mg, potassium 2 mg and sodium 2 mg
- does not meet USP requirements for preservative effectiveness
- store at 20-25ºC (68-77ºF)
- keep tightly closed
- Inactive ingredients
anhydrous citric acid, D&C red #28, flavor, glycerin, purified water, sorbitol solution, sucrose, xanthan gumClose
- Questions or comments?
- Principal Display Panel
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- INGREDIENTS AND APPEARANCE
LEADER MILK OF MAGNESIA
magnesium hydroxide liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-459 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 ANHYDROUS CITRIC ACID D&C RED NO. 28 GLYCERIN WATER SORBITOL SUCROSE XANTHAN GUM Product Characteristics Color PINK (Opaque Light pink) Score Shape Size Flavor CHERRY (wild cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-459-40 355 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/19/2005 Labeler - Cardinal Health (097537435)