Kirkland Signature Laxaclear Original Prescription Strength (Polyethylene Glycol 3350) Powder, For Solution [Costco Wholesale Company] -

KIRKLAND SIGNATURE LAXACLEAR ORIGINAL PRESCRIPTION STRENGTH (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [COSTCO WHOLESALE COMPANY]
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NDC	63981-306-03, 63981-306-04, 63981-306-07
Set ID	f58fa5c0-8ab7-4427-aea0-d536b47acbb5
Category	HUMAN OTC DRUG LABEL
Packager	Costco Wholesale Company
Generic Name
Product Class
Product Number
Application Number	ANDA090685

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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 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 right away. (1-800-222-1222)
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

•

ensure that the powder is fully dissolved before drinking

•

do not drink if there are any clumps

•

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˚-25˚C (68˚-77˚F)

•

tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Inactive ingredients

none
Questions or comments?

1-800-719-9260
Principal Display Panel

COMPARE TO MIRALAX® active ingredient

LAXACLEAR®

Polyethylene Glycol 3350 Powder for Solution

Osmotic Laxative

Unflavored Powder – Grit Free

Relieves Occasional Constipation/Irregularity

Softens Stool

50 Once-Daily Doses

NET WT 29.9 OZ (850g)

INGREDIENTS AND APPEARANCE

KIRKLAND SIGNATURE LAXACLEAR ORIGINAL PRESCRIPTION STRENGTH
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-306
Route of Administration	ORAL

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

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63981-306-07	3 in 1 PACKAGE	01/24/2011
1		510 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:63981-306-03	510 g in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2011
3	NDC:63981-306-04	850 g in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2009