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  5. Label Information: Miralax

FDA Label for Miralax

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH DOSE) (BOTTLE ONLY)
    3. PURPOSE
    4. ACTIVE INGREDIENT (IN EACH DOSE) (PACKET ONLY)
    5. USE
    6. ALLERGY ALERT
    7. OTC - DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS (BOTTLE ONLY)
    15. DIRECTIONS (PACKET ONLY)
    16. OTHER INFORMATION
    17. INACTIVE INGREDIENTS
    18. QUESTIONS OR COMMENTS?
    19. PRINCIPAL DISPLAY PANEL - 17 G × 3 PACKET CARTON
    20. PRINCIPAL DISPLAY PANEL - TWIN PACK - 765 G BOTTLE LABEL
    21. PRINCIPAL DISPLAY PANEL - 510 G BOTTLE LABEL
    22. PRINCIPAL DISPLAY PANEL - 17 G × 10 PACKET CARTON

Miralax Product Label

The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. 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.

Other



Drug Facts


Active Ingredient (In Each Dose) (Bottle Only)



Polyethylene Glycol 3350, 17 g (cap filled to line)


Purpose



Osmotic Laxative

Osmotic Laxative


Active Ingredient (In Each Dose) (Packet Only)



Polyethylene Glycol 3350, 17 g


Use



  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

Allergy Alert



Do not use if you are allergic to polyethylene glycol


Otc - Do Not Use



Do not use if you have kidney disease, except under the advice and supervision of a doctor


Ask A Doctor Before Use If You Have



  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

Otc - Ask Doctor/Pharmacist



Ask a doctor of pharmacist before use if you are taking a prescription drug


Otc - When Using



When using this product you may have loose, watery, more frequent stools


Stop Use And Ask A Doctor If



  • you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition.
  • you get diarrhea
  • you need to use a laxative for longer 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions (Bottle Only)



  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
  • adults and children 17 years of age and older:
    • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once a day
    • use no more than 7 days
    • children 16 years of age or under: ask a doctor

Directions (Packet Only)



  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once a day
    • use no more than 7 days
    • children 16 years of age or under: ask a doctor

Other Information



  • store at 20°-25°C (68°-77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredients



none


Principal Display Panel - 17 G × 3 Packet Carton



Trial
Pack

NDC 11523-7341-02

MiraLAX ®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED
POWDER
GRIT FREE

  • Relieves Occasional
    Constipation/Irregularity
  • Softens Stool

    • NeatPAX ®

    3 ONCE-DAILY DOSES

    3 PACKETS
    NET WT 0.5 OZ (17g) EACH


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