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NDC 63868-0002-30 NATURA-LAX 17 g/17g Details

NATURA-LAX 17 g/17g

NATURA-LAX is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. 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: 63868-0002-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	63868-0002
Product ID	63868-002_ee3b0446-97a6-1d86-e053-2995a90a239d
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	NATURA-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	Chain Drug Marketing Association
Pharmaceutical Class	Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090812
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0002-30 (63868000230)

Pricing Information
NDC Package Code	63868-002-30
Billing NDC	63868000230
Package	510 g in 1 BOTTLE (63868-002-30)
Marketing Start Date	2020-10-01
NDC Exclude Flag	N
Price Per Unit	0.02246
Pricing Unit	GM
Effective Date	2022-11-23
NDC Description	QC NATURA-LAX 17 GM POWDER
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-11-23

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 67f7c248-59d1-4202-bbca-f006b709c941 Details

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17g (cap filled to the indicated “17 GRAMS” line)

Purpose

Osmotic Laxative

Uses

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.

Directions

do not take more than directed unless advised by your doctor
the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
adults and children 17 years of age and older:
use once a day
fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
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
do not use 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 foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive ingredients

none

Questions or comments?

1-877-288-1495

Package label

INGREDIENTS AND APPEARANCE

NATURA-LAX

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-002
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:63868-002-14	238 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC:63868-002-30	510 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090812	05/01/2014

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2022

Document Id: ee3b0446-97a6-1d86-e053-2995a90a239d

Set id: 67f7c248-59d1-4202-bbca-f006b709c941

Version: 3

Effective Time: 20221124