POLYETHYLENE GLYCOL powder, for solution

Polyethylene Glycol by

Drug Labeling and Warnings

Polyethylene Glycol by is a Otc medication manufactured, distributed, or labeled by Harmon Stores, Inc, Strides Shasun Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

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

Purpose

Osmotic Laxative

Use

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

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 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.

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

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

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

SPL UNCLASSIFIED SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 63940-762-04

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

14 Once-Daily Doses

NET WT 8.3 OZ (238 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 63940-762-05

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

30 Once-Daily Doses

NET WT 17.9 OZ (510 g)

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 
polyethylene glycol powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-762
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 17 g

Product Characteristics
Color	WHITE ((colorless upon dissolution))	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-762-03	119 g in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2016
2	NDC: 63940-762-04	238 g in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2016
3	NDC: 63940-762-05	510 g in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	08/24/2016

Labeler - Harmon Stores, Inc (804085293)

Registrant - Strides Shasun Limited (918513263)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Shasun Limited		918513263	ANALYSIS(63940-762) , MANUFACTURE(63940-762) , PACK(63940-762)