Your browser does not support JavaScript! BERKLEY AND JENSEN CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BJWC]
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RxNorm Names

BERKLEY AND JENSEN CLEARLAX (polyethylene glycol 3350) powder, for solution
[BJWC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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, 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
•
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?

1-800-934-1204

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF MIRALAX®

ORIGINAL PRESCRIPTION STRENGTH

ClearLax®

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

Relieves Occasional Constipation

(Irregularity) / Softens Stool

# Once-daily Doses {Replace "#" with number daily doses}

ClearLax Front Label Image
ClearLax Back Label Image
BERKLEY AND JENSEN CLEARLAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-306
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68391-306-03510 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068512/17/2009
Labeler - BJWC (159082692)

Revised: 01/2013
Document Id: 48d69665-5864-4b12-9525-4a9f0ae282db
Set id: f9eb9023-c83b-49b4-af82-d8344ffa46c3
Version: 2
Effective Time: 20130117
 
BJWC

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