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NDC 36800-0306-09 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.

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 36800-0306-09 (36800030609)

Pricing Information	N/A
NDC Package Code	36800-306-09
Billing NDC	36800030609
Package	765 g in 1 BOTTLE (36800-306-09)
Marketing Start Date	2022-09-26
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