TOPCARE CLEARLAX- polyethylene glycol 3350 powder, for solution

Topcare ClearLax by

Drug Labeling and Warnings

Topcare ClearLax by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• 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?

1-888-423-0139

Principal Display Panel

COMPARE TO MIRALAX® ACTIVE INGREDIENT

UNFLAVORED POWDER - GRIT FREE

ClearLax®

POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION

OSMOTIC LAXATIVE

OUR PHARMACISTS RECOMMEND

Relieves Occasional Constipation (Irregularity)

Softens Stool

2 BOTTLES – NET WT 29.9 OZ (850g) Each

TOTAL NET WT 59.8 OZ (1700g)

100 ONCE-DAILY DOSES

INGREDIENTS AND APPEARANCE

TOPCARE CLEARLAX 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-306
Route of Administration	ORAL

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  in 17 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-306-01	119 g in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
2	NDC: 36800-306-02	238 g in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
3	NDC: 36800-306-03	507 g in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
4	NDC: 36800-306-04	850 g in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2011	03/05/2015
5	NDC: 36800-306-19	595 g in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2013
6	NDC: 36800-306-07	3 in 1 PACKAGE	10/07/2009
6		510 g in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 36800-306-08	2 in 1 PACKAGE	10/07/2009	10/07/2009
7		238 g in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 36800-306-20	2 in 1 PACKAGE	03/18/2020
8		850 g in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Topco Associates LLC (006935977)