Miralax Powder, For Solution
FDA Label NDC 55154-5035

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Miralax (NDC 55154-5035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each dose) (packet only), purpose, use, allergy alert, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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