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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 5 ML) ONE TEASPOONFUL)
    2. PURPOSE
    3. USE
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS

Milk Of Magnesia Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. 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 5 Ml) One Teaspoonful)



Magnesium Hydroxide 400 mg


Purpose



Saline laxative/Antacid


Use



Laxative

  • •relieves occasional constipation (irregularity).
  • •generally produces bowel movement in ½ to 6 hours.

    • Antacid

    • •relieves acid indigestion, sour stomach, heartburn.

Ask A Doctor Before Use If You Have



  • •kidney disease
  • •stomach pain, nausea or vomiting
  • • notice a sudden change in bowel habits that persists over a period of 2 weeks
  • •a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug. Antacid may interact with certain prescription drugs.


When Using This Product



  • •it may have a laxative effect
  • •do not exceed the maximum recommended daily dosgae in a 24-hour period

Stop Use And Ask A Doctor If



Laxative

  • •you have rectal bleeding or failure to have a bowel movement after use. These may indicate a serious condition.
  • •you need to use a laxative for more than one week

    • Antacid

    • •symptoms last for more than 2 weeks.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of accidental overdose, get medical help or contact a Poison Control Center immediately.


Directions



  • •shake well before use
    • Laxative use:Antacid use

    Do not use dosage cup for ages under 12 years.

    Follow each dose with a full glass (8 oz) of liquid.

    Do not use dosage cup.

    Follow each dose with a little water.

    adults and children 12 years and older2-4 TBSP (30-60 mL) once a day1-3 tsp (5-15 mL) up to 4 times a day
    6 to 11 years1-2 TBSP (15-30 mL) once a dayask a doctor
    2 to 5 years1-3 tsp (5-15 mL) once a dayask a doctor
    under 2 yearsask a doctorask a doctor

Other Information



  • •TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
  • •Store at room temperature 15° - 30°C (59° - 86°F)
  • •keep tightly closed
  • •keep from freezing
  • •each teaspoon (5 mL) contains: magnesium 166 mg
  • •each teaspoon (5 mL) contains: sodium 1 mg

Inactive Ingredients



citric acid, flavor, purified water, sodium hypochlorite.


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