CLEARLAX- polyethylene glycol powder, for solution

Clearlax by

Drug Labeling and Warnings

Clearlax by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CLEARLAX 
polyethylene glycol powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-566(NDC:0113-0306)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-566-10	10 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090685	10/07/2009

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK