1. Home
  2. Labeler Index
  3. Cardinal Health 107, Llc
  4. 55154-5035
  5. Label Information: Miralax

FDA Label for Miralax

View Indications, Usage & Precautions

Table of Contents

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

Miralax Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, 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

Bayer, the Bayer Cross, MiraLAX are registered trademarks of Bayer.

Dist. By: Bayer HealthCare LLC

Whippany, NJ 07981

NeatPAX is a trademark owned by its respective owner.

Repackaged by Cardinal Health

Zanesville, OH 43701

L4532222-11017

L4532222-21017


Active Ingredient (In Each Dose) (Packet Only)



Polyethylene Glycol 3350, 17 g


Purpose



Osmotic Laxative, powder for Solution

Unflavored powder grit free

Each Packet contains one dose, net wt 0.5 oz (17g)

Mix-In Pax

Travel Size

Relieves occasional constipation / irregularity

Softens stool

ONCE-DAILY DOSES


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 or 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 your nausea, bloating, 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.

This Unit dose package is not child resistant and is intended for Institutional Use Only. Keep this and all drugs out of the reach of children.


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 is open or broken
  • •Unflavored
  • •Sugar Free
  • •Dissolves in any Beverage

Inactive Ingredients



none


Questions Or Comments?



1-800-MiraLAX (1-800-647-2529)


Principal Display Panel



MiraLAX

Polyethylene Glycol 3350,

Powder for Solution, Osmotic Laxative

6 Packets


* Please review the disclaimer below.