TOPCARE CLEARLAX- polyethylene glycol 3350 powder, for solution 
Topco Associates LLC

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Topco Associates LLC. ClearLax® 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 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:
use once a day
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
do not combine with starch-based thickeners used for difficulty swallowing
ensure that the powder is fully dissolved before drinking
do not drink if there are any clumps
do not use 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

natural and artificial orange flavor, sucralose

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO MIRALAX® ACTIVE INGREDIENT

POWDER

GRIT FREE

ClearLax®

POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION

OSMOTIC LAXATIVE

● Relieves Occasional Constipation (Irregularity)

● Softens Stool

● Sugar-free

● Dye-free

ORANGE FLAVORED POWDER

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

ClearLax Front Label
ClearLax Back Label
TOPCARE CLEARLAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-119-02238 g in 1 BOTTLE; Type 0: Not a Combination Product01/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068501/30/2024
Labeler - Topco Associates LLC (006935977)

Revised: 2/2024
Document Id: 57254ac5-729d-4aae-863d-b57a67053aec
Set id: 02f81a86-bec5-4e8b-bddb-d463ae2ea9e9
Version: 2
Effective Time: 20240207
 
Topco Associates LLC