Search by Drug Name or NDC

NDC 63187-0368-23 GAVILAX 17 g/17g Details

GAVILAX 17 g/17g

GAVILAX 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.

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: 63187-0368-23
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	63187-0368
Product ID	63187-368_f28b44fb-7018-43ee-9d1b-c8d6bdcb7894
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	GAVILAX
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	ANDA091077
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0368-23 (63187036823)

Pricing Information	N/A
NDC Package Code	63187-368-23
Billing NDC	63187036823
Package	238 g in 1 BOTTLE (63187-368-23)
Marketing Start Date	2016-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 199d6173-3fad-49e4-88fe-bde7223ed4c3 Details

Active Ingredient

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 the 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.
•: adults and children 17 years of age and older:
•: fill to top of line 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 Ingredient

none

Questions or comments?

1-866-403-7592

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63187-368-23

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

GAVILAX

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-368(NDC:43386-312)
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

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-368-23	238 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091077	10/09/2009

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-368) , RELABEL(63187-368)

Revised: 6/2022

Document Id: f28b44fb-7018-43ee-9d1b-c8d6bdcb7894

Set id: 199d6173-3fad-49e4-88fe-bde7223ed4c3

Version: 6

Effective Time: 20220601