EASYLAX- polyethylene glycol powder

EasyLAX by

Drug Labeling and Warnings

EasyLAX by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene Glycol 3350,

17 g (cap filled to line)

Purpose

Osmotic laxative

Uses

• 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, vomitting or abdominal pain
• a sudden change in bowel habits that lasts over 2 weeks
• irritable bowel syndrome

Ask a doctor or 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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
• adults and children 17 years of age and older:
  • fill to top of line in cap which is marked to indicate the correct dose (17 g)
  • stir and dissolve in any 4 to 8 ounce 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 20-25ºC (68-77ºF)

Inactive ingredient

none

Questions or comments?

Or to report an adverse event Call 800-824-1706 Monday - Friday 9am -4pm MST

Principal Display Panel

*Compare to the active ingredient in MIRALAX®

ORIGINAL PRESCRIPTION STRENGTH

EasyLax

Polyethylene Glycol 3350

POWDER FOR ORAL SOLUTION

OSMOTIC LAXATIVE

Relieves Occasional Constipation  (Irregularity)

Softens stool

Sugar Free 

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Polyethylene glycol 3350 increases frequency of bowel movements and softens the stool

*This product is not manufactured or distributed by BAYER HEALTHCARE LLC, distributor of MIRALAX®.

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

Package Label

WinCo Foods EasyLax Original Prescription Strength

INGREDIENTS AND APPEARANCE

EASYLAX 
polyethylene glycol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-306
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-306-83	238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2016	12/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091077	08/31/2016	12/30/2020

Labeler - WinCo Foods, LLC (056098817)