Miralax ®

Miralax ®
SPL v23
SPL
SPL Set ID d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Route
ORAL
Published
Effective Date 2019-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2007-02-01 Until 2018-01-01

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.

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 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)

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 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:
    • use once a day
    • stir and dissolve one packet of powder (17 g) 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
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
Active Ingredient (in Each Dose) (bottle Only)

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

Active Ingredient (in Each Dose) (packet Only)

Polyethylene Glycol 3350, 17 g

Principal Display Panel 17 G × 10 Packet Carton

10

Single Doses

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Mix-In Pax ®

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

10

ONCE-DAILY DOSES

Bayer

Unflavored Powder Dissolves in ANY Beverage!

UNFLAVORED

POWDER

GRIT FREE

10 PACKETS

NET WT 0.5 OZ

(17g) EACH

Principal Display Panel 17 G × 20 Packet Carton

20

Single Doses

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Mix-In Pax ®

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

20

ONCE-DAILY DOSES

Bayer

Unflavored Powder Dissolves in ANY Beverage!

UNFLAVORED

POWDER

GRIT FREE

20 PACKETS

NET WT 0.5 OZ

(17g) EACH

Principal Display Panel 30 Dose (510 G) Bottle Label

Easy to Pour Bottle

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Bayer

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Principal Display Panel Twinpack 2x34 Dose (578 G) Bottle Label

Twin Pack!

2 x 34 Doses

Easy to Pour Bottle

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

#1 DOCTOR RECOMMENDED BRAND

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED

POWDER

GRIT FREE

Bayer

34 ONCE-DAILY DOSES

NET WT 20.4 OZ (578 g)


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.

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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredients (Inactive ingredients)

none

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 no more than 7 days
  • children 16 years of age or under: ask a doctor
Directions (packet Only) (Directions (Packet Only))
  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • use once a day
    • stir and dissolve one packet of powder (17 g) 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
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
Active Ingredient (in Each Dose) (bottle Only) (Active ingredient (in each dose) (Bottle Only))

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

Active Ingredient (in Each Dose) (packet Only) (Active ingredient (in each dose) (Packet Only))

Polyethylene Glycol 3350, 17 g

Principal Display Panel 17 G × 10 Packet Carton (PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton)

10

Single Doses

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Mix-In Pax ®

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

10

ONCE-DAILY DOSES

Bayer

Unflavored Powder Dissolves in ANY Beverage!

UNFLAVORED

POWDER

GRIT FREE

10 PACKETS

NET WT 0.5 OZ

(17g) EACH

Principal Display Panel 17 G × 20 Packet Carton (PRINCIPAL DISPLAY PANEL - 17 g × 20 Packet Carton)

20

Single Doses

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

Mix-In Pax ®

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

20

ONCE-DAILY DOSES

Bayer

Unflavored Powder Dissolves in ANY Beverage!

UNFLAVORED

POWDER

GRIT FREE

20 PACKETS

NET WT 0.5 OZ

(17g) EACH

Principal Display Panel 30 Dose (510 G) Bottle Label (PRINCIPAL DISPLAY PANEL - 30 Dose (510 g) Bottle Label)

Easy to Pour Bottle

#1 DOCTOR RECOMMENDED BRAND

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

UNFLAVORED

POWDER

GRIT FREE

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Bayer

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Principal Display Panel Twinpack 2x34 Dose (578 G) Bottle Label (PRINCIPAL DISPLAY PANEL - Twinpack 2x34 Dose (578 g) Bottle Label)

Twin Pack!

2 x 34 Doses

Easy to Pour Bottle

MiraLAX ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

#1 DOCTOR RECOMMENDED BRAND

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED

POWDER

GRIT FREE

Bayer

34 ONCE-DAILY DOSES

NET WT 20.4 OZ (578 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)