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  5. Label Information: Milk Of Magnesia

FDA Label for Milk Of Magnesia

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Milk Of Magnesia Product Label

The following document was submitted to the FDA by the labeler of this product Llc Federal Solutions. 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.

Otc - Active Ingredient



Active ingredient (in each 15 mL tablespoonful)
Magnesium hydroxide 1200 mg


Otc - Purpose



Purpose
Saline laxative


Indications & Usage



Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours

Warnings



Warnings


Otc - Ask Doctor



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 over 14 days

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking a prescription drug.
This product may interact with certain prescription drugs.


Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away.


Dosage & Administration



Directions

  • 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


    • adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)
    children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)
    children under 6 years: ask a doctor


Other Safety Information



Other information

  • each 15 mL tablespoonful contains: magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use

Inactive Ingredient



Inactive ingredients
purified water, sodium hypochlorite


Package Label.Principal Display Panel





———PRINCIPAL DISPLAY PANEL———NDC: 24451-788-30
MILK OF MAGNESIA
DELIVERS 30 mL
CONTAINING:
MAGNESIUM HYDROXIDE
2400 mg
SALINE LAXATIVE
ORIGINAL FLAVOR
SUGAR FREE
SHAKE WELL
Exp: 00/00/00   Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

product label - product label

product label - product label


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