MedPath

GAVILAX

Approved
Approval ID

c9688f06-b6db-4afb-b8ff-ef5fb8bf9946

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Polyethylene Glycol 3350

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-0312
Application NumberANDA091077
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polyethylene Glycol 3350
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (2)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYETHYLENE GLYCOL 3350Active
Quantity: 17 g in 17 g
Code: G2M7P15E5P
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/26/2021

GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION

1

2

3

4

5

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2013

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2013

Active Ingredient

Polyethylene Glycol 3350, 17 g (cap filled to line)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2013

Purpose

Osmotic Laxative

Use

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2013

Warnings

**Allergy alert:**Do not use if you are allergic to polyethylene glycol

Do not useif you have kidney disease, except under the advice and supervision of a doctor

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/20/2013

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 productyou may have loose, watery, more frequent stools

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/23/2013

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/23/2013

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)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2013

Inactive Ingredient

none

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/18/2013

Questions or comments?

1-866-403-7592

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