CLEARLAX- polyethylene glycol powder, for solution 
Rebel Distributors Corp

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Drug Facts

Active ingredient

Polyethylene Glycol

Purpose

Use(s)

• relieves occasional constipation (irregularity)

• generally produces a bowel movement in 1 to 3 days

Keep Out of Reach of Children

Uses

Use(s)

• relieves occasional constipation (irregularity)

• generally produces a bowel movement in 1 to 3 days

Warnings

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

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions

• do not take more than directed unless advised by your doctor

• adults and children 17 years of age and older:

• stir and dissolve one packet of powder (17 g) 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

• 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 pouch is open or broken (Pouch Carton Only)

• tamper-evident: do not use if printed foil seal under cap is missing, open or broken (Label Only)

Inactive ingredients

Inactive ingredients

none

Package/Label Principal Display Panel

Clearlax (Polyethylene Glycol) 17gm

CLEARLAX 
polyethylene glycol powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-566(NDC:0113-0306)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-566-1010 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068510/07/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 1/2011
Document Id: da73cc74-908f-4497-8770-6c1d774f5ce2
Set id: da73cc74-908f-4497-8770-6c1d774f5ce2
Version: 1
Effective Time: 20110112
 
Rebel Distributors Corp