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NDC 71205-0447-38 Good Sense Clear Lax 17 g/17g Details

Good Sense Clear Lax 17 g/17g

Good Sense Clear Lax is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is POLYETHYLENE GLYCOL 3350.

Product Information

NDC	71205-0447
Product ID	71205-447_9c48f05e-92d9-47de-9ee9-0517640f5ac4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Good Sense Clear Lax
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	Proficient Rx LP
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 71205-0447-38 (71205044738)

Pricing Information	N/A
NDC Package Code	71205-447-38
Billing NDC	71205044738
Package	238 g in 1 BOTTLE (71205-447-38)
Marketing Start Date	2020-04-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0858a914-4812-4e4d-82f8-ecf93d43ef3b 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
•: 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

Unflavored Powder Grit Free

ClearLax®

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

Relieves Occasional Constipation / Irregularity

Softens Stool

Compare to active ingredient of MiraLAX®

NET WT 8.3 OZ (238 g)

14 Once-Daily Doses

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

GOOD SENSE CLEAR LAX

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-447(NDC:0113-0306)
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:71205-447-38	238 g in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

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

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-447) , RELABEL(71205-447)

Revised: 7/2022

Document Id: 9c48f05e-92d9-47de-9ee9-0517640f5ac4

Set id: 0858a914-4812-4e4d-82f8-ecf93d43ef3b

Version: 3

Effective Time: 20220701