Polyethylene Glycol 3350 Powder For Solution

Polyethylene Glycol 3350 Powder For Solution
SPL v1
SPL
SPL Set ID 3fd415b7-3d17-47ff-86b1-9eeac5f20271
Route
ORAL
Published
Effective Date 2017-05-04
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
ANDA Active Since 2016-08-24

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

Directions
  • 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
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

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredient

none

Questions Or Comments?

1-877-753-3935

Made in India

*Miralax® is a registered trademark of Bayer Consumer Care Holdings LLC

Distributed by Liberty

Procurement, Inc.650 Liberty

Ave. Union, NJ 07083 USA

Visit us at: www.facevalues.com

Revised: 01/2017

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.

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

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
Package Label.principal Display Panel

NDC 63940-762-03

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in any beverage
  • Sugar Free

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

7 Once-Daily Doses

NET WT 4.15 OZ (119 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

Purpose

Osmotic Laxative

Directions
  • 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
Allergy Alert (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

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredient

none

Questions Or Comments? (Questions or comments?)

1-877-753-3935

Made in India

*Miralax® is a registered trademark of Bayer Consumer Care Holdings LLC

Distributed by Liberty

Procurement, Inc.650 Liberty

Ave. Union, NJ 07083 USA

Visit us at: www.facevalues.com

Revised: 01/2017

Stop Use and Ask A Doctor If (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.

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

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
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 63940-762-03

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in any beverage
  • Sugar Free

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

7 Once-Daily Doses

NET WT 4.15 OZ (119 g)


Advanced Ingredient Data


Raw Label Data

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