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NDC 70000-0415-02 leader clearlax 17 g/17g Details

leader clearlax 17 g/17g

leader clearlax is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0415-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	70000-0415
Product ID	70000-0415_abf92abe-b5f3-4925-823f-5b28d0b15253
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	leader 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	Cardinal Health 110, LLC. dba Leader
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 70000-0415-02 (70000041502)

Pricing Information
NDC Package Code	70000-0415-2
Billing NDC	70000041502
Package	238 g in 1 BOTTLE (70000-0415-2)
Marketing Start Date	2019-02-19
NDC Exclude Flag	N
Price Per Unit	0.02425
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	CLEARLAX POWDER
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 812c59b0-e7ce-4c7a-91ed-e74b7b1b84be 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:
•: 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
•: ensure that the powder is fully dissolved before drinking
•: do not drink if there any clumps
•: 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?

1-800-719-9260

Principal Display Panel

Grit-Free | Unflavored Powder

ClearLax®

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

COMPARE TO MIRALAX® active ingredient

Relieves Occasional Constipation/Irregularity

Softens Stool

7 ONCE-DAILY DOSES

100% Money Back Guarantee

NET WT 4.1 OZ (119 g)

INGREDIENTS AND APPEARANCE

LEADER CLEARLAX

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0415
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
Packaging
1	NDC:70000-0415-1	119 g in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2018
2	NDC:70000-0415-3	510 g in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2019
3	NDC:70000-0415-2	238 g in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090685	12/27/2018

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 4/2021

Document Id: abf92abe-b5f3-4925-823f-5b28d0b15253

Set id: 812c59b0-e7ce-4c7a-91ed-e74b7b1b84be

Version: 5

Effective Time: 20210421