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NDC 36800-0306-01 Topcare ClearLax 17 g/17g Details

Topcare ClearLax 17 g/17g

Topcare ClearLax is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is POLYETHYLENE GLYCOL 3350.

MedlinePlus Drug Summary

Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.

Related Packages: 36800-0306-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	36800-0306
Product ID	36800-306_a0200973-ece3-40b5-9ef5-898ce84ef347
Associated GPIs	46600033002910
GCN Sequence Number	041843
GCN Sequence Number Description	polyethylene glycol 3350 POWDER 17 G/DOSE ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	86212
HICL Sequence Number	022819
HICL Sequence Number Description	POLYETHYLENE GLYCOL 3350
Brand/Generic	Generic
Proprietary Name	Topcare ClearLax
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyethylene Glycol 3350
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER, FOR SOLUTION
Route	ORAL
Active Ingredient Strength	17
Active Ingredient Units	g/17g
Substance Name	POLYETHYLENE GLYCOL 3350
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090685
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0306-01 (36800030601)

Pricing Information	N/A
NDC Package Code	36800-306-01
Billing NDC	36800030601
Package	119 g in 1 BOTTLE (36800-306-01)
Marketing Start Date	2009-10-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 03291fd3-7b64-4b79-ad84-e1b9b30a6b03 Details

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
•: 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

TopCare® health

COMPARE TO MIRALAX® ACTIVE INGREDIENT

UNFLAVORED POWDER • GRIT FREE

ClearLax®

POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION

OSMOTIC LAXATIVE

• Relieves Occasional Constipation (Irregularity)

• Softens Stool

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	12/01/2022
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
9	NDC:36800-306-09	765 g in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2022

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

Labeler - Topco Associates LLC (006935977)

Revised: 11/2022

Document Id: a0200973-ece3-40b5-9ef5-898ce84ef347

Set id: 03291fd3-7b64-4b79-ad84-e1b9b30a6b03

Version: 11

Effective Time: 20221114