MiraLAX

What is MiraLax and how is it used?

MiraLax is an over the counter and prescription medicine used to treat the symptoms of constipation or for Bowel Preparation. MiraLax may be used alone or with other medications.

MiraLax belongs to a class of drugs called Laxatives, Osmotic; Bowel Preps

.It is not known if MiraLax is safe and effective in children younger than 6 months of age.

What are the possible side effects of MiraLax?

MiraLax may cause serious side effects including:

• severe or bloody diarrhea,
• rectal bleeding,
• blood in your stools, and
• severe or worsening stomach pain

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of MiraLax include:

• bloating,
• gas,
• upset stomach,
• dizziness, and
• increased sweating

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of MiraLax. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Active ingredient

(in each dose) (Bottle Only): Polyethylene Glycol 3350, 17 g (cap filled to line)

Inctive ingredient

None

INDICATIONS

Purpose

Osmotic Laxative

Use

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

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Storage

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 17 g × 3 Packet Carton

Trial Pack

NDC 11523-7341-02

Manufactured by: Bayer HealthCare LLC. Revised: Mar 2017

SIDE EFFECTS

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 of 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 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

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

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

DRUG INTERACTIONS

No information provided.

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 of 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 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

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

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

PRECAUTIONS

See section above

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

CLINICAL PHARMACOLOGY

No information provided.

PATIENT INFORMATION

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 of 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 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

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

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