MiraLAX® Logo — doctor recommended,
patient approved

MiraLAX is the ONLY OTC osmotic laxative with a prescription heritage and is favored by both physicians and patients1

MiraLAX is supported by 19 years of safe and effective use

FDA-approved as an OTC product in 2006

AGA 1st line recommendation #1 GI-recommended laxative 96% patient satisfaction rate

MiraLAX provides predictable and reliable relief for a broad range of patients

men and women
WOMEN AND MEN
17 years of age and older4
elderly man
ELDERLY PATIENTS
65 years of age and older5
doctor with patient
PATIENTS TAKING CONSTIPATION-CAUSING MEDICATIONS6
patient reading prescription
PATIENTS ON OTHER MEDICATIONS
No known drug-to-drug interactions
Feel confident recommending MiraLAX for gentle relief
of occasional constipation
References: 1. Food and Drug Administration. Approval letter for new drug application for MiraLAX powder; February 18, 1999; Rockville, Maryland. https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020698.cfm. 2. Bharucha AE, Dorn SD, Lembo A, Pressman A; American Gastroenterological Association. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013;144(1):211-217. 3. Survey of 672 consumers, August 2017, Bayer Consumer Health. 4. MiraLAX Drug Facts. Bayer HealthCare. 5. DiPalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007;102(7);1436-1441. 6. DiPalma JA, Cleveland MB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007;100(11):1085-1090.

MiraLAX® Logo works
differently to provide predictable relief

The gentle power of MiraLAX softens stool and relieves constipation1-5

Works naturally with the water in the body

As an osmotic laxative, MiraLAX attracts water in the colon to ease, hydrate, and soften stool1,2

Helps patients have a comfortable experience

Relieves occasional constipation without causing gas, bloating, cramping, or sudden urgency3,4

In multiple clinical trials, MiraLAX has been proven to

droplets feather cloud
Increase water content of
stool, softening to
ease passage1,2
24 to 72 hours
Result in a bowel
movement within
24 to 72 hours8
colon
Significantly increase the
frequency of bowel
movements vs placebo3-5
References: 1. Hammer HF, Santa Ana CA, Schiller LR, Fordtran JS. Studies of osmotic diarrhea induced in normal subjects by ingestion of polyethylene glycol and lactulose. J Clin Invest. 1989;84(4):1056-1062. doi:10.1172/JCl114267 2. Schiller LR, Emmett M, Santa Ana CA, Fordtran JS. Osmotic effects of polyethylene glycol. Gastroenterology. 1988;94(4):933-941. 3. DiPalma JA, DeRidder PH, Orlando RC, Kolts BE, Cleveland MB. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95(2):446-450. 4. DiPalma JA, Cleveland MB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007;100(11):1085-1090. 5. Cleveland MV, Flavin DP, Ruben RA, Epstein RM, Clark GE. New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. South Med J. 2001;94(5):478-481. 6. Bassotti G, Chiarioni G, Germani U, Battaglia E, Vantini I, Morelli A. Endoluminal instillation of bisacodyl in patients with severe (slow transit type) constipation is useful to test residual colonic propulsive activity. Digestion. 1999;60(1):69-73. 7. Frexinos J, Staumont G, Fioramonti J, Bueno L. Effects of sennosides on colonic myoelectrical activity in man. Dig Dis Sci. 1989;34(2):214-219. 8. MiraLAX [drug facts]. Bayer HealthCare.

Summary of key MiraLAX® Logo
clinical studies and analyses

MiraLAX is supported by 19 years of safe and effective use

  • Evaluated the safety and effectiveness of MiraLAX in 151 people with constipation
  • Patients were given either MiraLAX or a placebo, and kept track of any changes in how often they had bowel movements as well as associated subjective symptoms
  • After 2 weeks, patients who took MiraLAX had significantly (P<0.001) more bowel movements as well as significantly less severe cramping and gas (P<0.001)
Find out more
  • Evaluated the safety and effectiveness of MiraLAX laxative in people with constipation
  • Twenty-three patients with constipation were given the normal daily dose (17 g) of MiraLAX or a placebo, after which they recorded each bowel movement and associated symptoms in a diary and watched for any changes in how often they had bowel movements
  • After 14 days, patients given MiraLAX had significantly more bowel movements than those on placebo (7.0 vs 3.6, respectively, in week 2; P<0.001), and they had no serious side effects
Find out more
  • Randomized clinical trials conducted between 1966 and 2003 were identified to evaluate the safety and efficacy of different laxatives
  • Polyethylene glycol received Level 1, Grade A ratings
    • Level 1: Consistent results from well-designed, well-conducted studies
    • Grade A ratings for efficacy and safety: Good evidence in support of the use of a modality in the treatment of constipation
Find out more
  • Patients taking constipation-inducing medications (≥3% incidence of constipation) were randomized to treatment with 17 g PEG 3350 (n=50) daily or placebo (n=50) for 28 days
  • The primary efficacy variable of treatment success was based on the presence of no more than one of the following in 25% of bowel movements or <3 bowel movements per week over the last 7 days of treatment:
    • Straining
    • Lumpy/hard stool
    • Incomplete evacuation
    • Anorectal obstruction
    • Manual maneuvers
  • PEG 3350 was significantly superior vs placebo in the primary efficacy endpoint of treatment success: 78.3% vs 39.1% (P<0.001), respectively
  • Statistically significant difference in favor of PEG 3350 over placebo were observed:
    • After first week of treatment:
      • Total number of bowel movements per week
      • Number of complete bowel movements
      • Number of satisfactory bowel movements
    • For all treatment weeks:
      • Straining
      • Stool consistency
  • There were no statistically significant treatment-emergent adverse events, including GI complaints
Find out more
  • Patients with modified Rome functional constipation criteria of <3 satisfactory bowel movements per week, with straining in >25% of defecations, hard or lumpy stools in >25% of defecations, or sensation of incomplete evacuation in >25% of defecations for a 3-month period were randomized to treatment with 17 g PEG 3350 (n=204) daily or placebo (n=100)
  • The primary efficacy variable of treatment success was defined as no rescue laxative use, ≥3 satisfactory stools per week, and ≤1 remaining symptom of the modified Rome criteria defined above
    • Significantly more PEG 3350 patients (52%) were successfully treated compared to placebo (11%, P<0.001)
  • PEG 3350 was significantly superior (P<0.001) to placebo for:
    • Number of bowel movements per week
    • Satisfactory bowel movements per week
    • Complete spontaneous bowel movements
  • While the individual GI adverse events did not differ significantly than with placebo, when combined these GI events (diarrhea, flatulence, loose stools, and nausea) occurred significantly more often with PEG than with placebo (40% vs 25%, P<0.015)
  • No clinically significant changes in laboratory test results were reported
Find out more
  • A 2011 Cochrane review identified and reviewed all randomized controlled trials comparing the use of lactulose and polyethylene glycol in the management of fecal impaction and chronic constipation (Rome III criteria) in adults and children. Both monotherapy and crossover studies were reviewed
  • The findings of this meta-analysis indicate that polyethylene glycol is better than lactulose in outcomes of stool frequency per week, form of stool, relief of abdominal pain, and the need for additional products
Find out more
References: 1. DiPalma JA, DeRidder PH, Orlando RC, Kolts BE, Cleveland MB. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95(2):446-450. 2. Cleveland MV, Flavin DP, Ruben RA, Epstein RM, Clark GE. New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. South Med J. 2001;94(5):478-481. 3. Ramkumar D, Rao S. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005;100(4):936-971. 4. DiPalma JA, Cleveland MB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007;100(11):1085-1090. 5. DiPalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007;102(7):1436-1441. 6. Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus polyethylene glycol for chronic constipation: review. Cochrane Database Syst Rev. 2010;7:1-38.

Start your patients on MiraLAX® Logo first

MiraLAX is available in a variety of dosing sizes, including travel-size packets

MiraLAX is easily accessible at national drug store chains, supermarkets, mass merchandisers, and club stores


				MiraLAX 7 dose bottle
				MiraLAX 14 dose bottle
				MiraLAX 30 dose bottle
				MiraLAX 45 dose bottle
Mix-In PAX TM Travel Size packets 10 count carton
Mix-In Pax Single-Serve Packets
Available in 3-, 10-, and 20-count packages
coffee, water, orange juice
Remind patients that MiraLAX is easy to take
The powder dissolves easily in water or any beverage
    —No taste or grit
    —Gluten and sugar free

MiraLAX® Logo drug facts

Active ingredient (in each dose)

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

Mix-In Pax: Polyethylene Glycol 3350, 17 g (per packet)

Purpose

Osmotic Laxative

Use

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 1 to 3 days

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol.

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

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

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

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Directions

  • Do not take more than directed unless advised by your doctor
  • For adults and children 17 years of age and older
  • For children 16 years of age or under: ask a doctor

Bottle

  • The bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
cap
Fill to 17 g indicator line
spoon in glass
Stir and dissolve in any 4 to 8 ounces of beverage (cold, hot, or room temperature), then drink
bottle and calendar
Use once a day
calendar
Use no more than 7 days

Mix-In Pax

  • Stir and dissolve 1 packet of powder (17 g) in any 4 to 8 once beverage (cold, hot, or room temperature), then drink
  • Use once a day
  • Use no more than 7 days

Other information (bottle)

  • 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

Other information (Mix-In Pax)

  • Store at 20°—25°C (68°—77°F)
  • Tamper-evident: do not use if foil is open or broken

Inactive ingredients

  • None

Questions or comments?

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