FDA.reportPublic FDA data

Gavilax Powder Solution Drug Facts

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:08:29

Label at a glance#

ProductGAVILAX
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure10 sections

Dosage and administration

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 tha...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Use

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

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

Stop use and ask a doctor if

DOSAGE & ADMINISTRATION SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

Directions

INDICATIONS & USAGE SECTION

  • 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

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-866-403-7592

GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

33

44

88

99

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876214GaviLAX 17 GM Powder for Oral SolutionPSN14
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN14
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBD14
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD14
876214Gavilax 17 GM Powder for Oral SolutionSY14
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY14

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0312-12025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-22025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-32025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-42025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-52025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-62025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-72025-03-04C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-12025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-22025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-32025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-42025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-52025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-62025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-72025-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-12023-10-10C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-22023-10-10C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-32023-10-10C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-42023-10-10C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-52023-10-10C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-62023-10-10C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-12023-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-22023-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-32023-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-42023-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-52023-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts
17856-0312-62023-01-30C16284748780-1f386c64a-1db9-0266-e053-dadaa90a7c1aGavilax Powder Solution Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0312-1GAVILAX17 g in 1 BAGPOWDER, FOR SOLUTION1714
17856-0312-2GAVILAX8.5 g in 1 BAGPOWDER, FOR SOLUTION8.514
17856-0312-3GAVILAX17 g in 1 CUPPOWDER, FOR SOLUTION1714
17856-0312-4GAVILAX4 g in 1 BAGPOWDER, FOR SOLUTION414
17856-0312-5GAVILAX8.5 g in 1 CUPPOWDER, FOR SOLUTION8.514
17856-0312-5GAVILAX50 in 1 CASEPOWDER, FOR SOLUTION5014
17856-0312-6GAVILAX72 in 1 CASEPOWDER, FOR SOLUTION7214
17856-0312-6GAVILAX4.5 g in 1 POUCHPOWDER, FOR SOLUTION4.514
17856-0312-7GAVILAX4.25 g in 1 BAGPOWDER, FOR SOLUTION4.2514
17856-0312-7GAVILAX50 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION5014
17856-0312-8GAVILAX72 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION7214
17856-0312-8GAVILAX4.25 g in 1 BAGPOWDER, FOR SOLUTION4.2514
17856-0312-9GAVILAX4.25 g in 1 CUPPOWDER, FOR SOLUTION4.2514
17856-0312-9GAVILAX50 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION5014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0312-1EA - Each17856-03122207a097-3cbf-4c66-9606-5314f8ea385e12016-04-04
17856-0312-2EA - Each17856-0312461d158a-8bd4-4386-89f9-2aab4b3d5dd712016-04-04
17856-0312-5EA - Each17856-03127ad8a14d-8374-41b3-9796-93916cd3d28e12024-05-16
17856-0312-6EA - Each17856-031235018d5e-acba-4c4d-a224-fc921c1f7e2812025-06-13
43386-312-08GM - Gram43386-31257798290-79a3-4b31-81dc-ba4a8f41a9db12012-07-24
43386-312-14GM - Gram43386-3128ab2f632-0a16-4655-9b64-514a838fe0e412012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-031217856-0312-1, 17856-0312-2, 17856-0312-3, 17856-0312-4, 17856-0312-7, 17856-0312-5, 17856-0312-6, 17856-0312-8, 17856-0312-9
43386-312

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091077-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06
A091077-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-2784e616aacf4f…
2026-08-18 06:07:402026-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063f0d92c62455…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsExact identifier
ndc (product): 43386-312
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
ndc (package): 17856-0312-7
ndc (package): 17856-0312-1
ndc (package): 17856-0312-9
ndc (package): 17856-0312-5
ndc (package): 17856-0312-3
ndc (package): 17856-0312-6
ndc (package): 17856-0312-8
ndc (package): 17856-0312-2
ndc (package): 17856-0312-4
ndc (product): 17856-0312
ndc11 (package): 17856031204
ndc11 (package): 17856031202
ndc11 (package): 17856031207
ndc11 (package): 17856031205
ndc11 (package): 17856031203
ndc11 (package): 17856031209
ndc11 (package): 17856031206
ndc11 (package): 17856031208
ndc11 (package): 17856031201
spl id: 3a86670e-4e74-3a85-e063-6394a90ad435
spl set id: c9688f06-b6db-4afb-b8ff-ef5fb8bf9946

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.