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  5. Label Information: Milk Of Magnesia

FDA Label for Milk Of Magnesia

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 15 ML)
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Milk Of Magnesia Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each 15 Ml)



Magnesium hydroxide 1200 mg


Purpose



Saline laxative


Uses



  • •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

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 (1-800-222-1222).


Directions



  • •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, 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
  • •mL = milliliter

    • adults and children 12

    years and older

    30 mL to 60 mL

    children 6 to 11 years

    15 mL to 30 mL

    children under 6 years

    ask a doctor


Other Information



  • •each 15 mL contains: calcium 20 mg, magnesium 595 mg, and sodium 2 mg
  • •does not meet USP requirements for preservative effectiveness
  • •store at 20-25°C (68-77°F)
  • •close cap tightly after use
  • •avoid freezing

Inactive Ingredients



light mineral oil, peppermint oil, purified water, saccharin sodium


Questions Or Comments?



1-800-616-2471


Principal Display Panel



Milk of Magnesia Saline Laxative

MINT FLAVOR

Effective overnight relief

Cramp free

Stimulant free

Sugar free

Compare to the Active Ingredient of Phillips’® Milk of Magnesia

12 FL OZ (355 mL)

Magnesium Hydroxide, 1200 mg per 15 mL

332-5c-milk-of-magnesia.jpg - 332 5c milk of magnesia

332-5c-milk-of-magnesia.jpg - 332 5c milk of magnesia


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