Miralax ®

Miralax ®
SPL v3
SPL
SPL Set ID 0a5b2121-928f-8f49-e063-6394a90a8aaf
Route
ORAL
Published
Effective Date 2023-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)
Inactive Ingredients
Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2023-09-15

Description

Drug Facts

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Drug Facts

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Section 50567-7

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

Section 50568-5

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

Section 50570-1

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

Section 53414-9

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

Allergy Alert

Do not use if you are allergic to polyethylene glycol

Other Information
  • store at 20°-25°C (68°-77°F)
  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Inactive Ingredients

natural and artificial orange flavor, sucralose

Questions Or Comments?

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

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:
    • use once a day
    • 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
    • do not combine with starch-based thickeners used for difficulty swallowing
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any clumps
    • do not use more than 7 days
  • children 16 years of age or under: ask a doctor
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
Active Ingredient (in Each Dose)

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

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
Principal Display Panel 7 Dose Bottle

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Relieves Occasional Constipation/Irregularity

Softens Stool

Grit-Free Powder

Sugar-Free & Dye-Free

ORANGE FLAVOR

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)

Bayer


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

Osmotic Laxative

Allergy Alert (Allergy alert)

Do not use if you are allergic to polyethylene glycol

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Inactive Ingredients (Inactive ingredients)

natural and artificial orange flavor, sucralose

Questions Or Comments? (Questions or comments?)

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

Directions (bottle Only) (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:
    • use once a day
    • 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
    • do not combine with starch-based thickeners used for difficulty swallowing
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any clumps
    • do not use more than 7 days
  • children 16 years of age or under: ask a doctor
Stop Use and Ask A Doctor If (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
Active Ingredient (in Each Dose) (Active ingredient (in each dose))

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

Ask A Doctor Before Use If You Have (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
Principal Display Panel 7 Dose Bottle (PRINCIPAL DISPLAY PANEL - 7 Dose Bottle)

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Relieves Occasional Constipation/Irregularity

Softens Stool

Grit-Free Powder

Sugar-Free & Dye-Free

ORANGE FLAVOR

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)

Bayer


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)