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

Purpose

Osmotic Laxative

Description

Drug Facts


Medication Information

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
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
Description

Drug Facts

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

Drug Facts

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

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

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

Drug Facts

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

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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