Instalax TM Polyethelene Glycol 3350, Powder for Solution, Osmotic Laxative

Manufacturer: Sun Pharmaceutical Industries, Inc. | Strides Pharma Science Limited
Effective date: 2026-07-24
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: daily-update
Hydrated at: 2026-07-28 05:10:17

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure11 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 (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section 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 temp...

Contacts and useful links#

PhoneLabel contact1-877-244-9825

Label contents#

Full prescribing information#

Polyethylene Glycol 3350, Powder for Solution

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert:

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking a prescription drug

OTC - WHEN USING SECTION

When using this productyou may have loose, watery, more frequent stools

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION 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 (white section in cap)
adults and children 17 years of age and older:
- use once a day
- fill to top of white section 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

SPL UNCLASSIFIED SECTION

store at 20° to 25°C (68° to 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

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-877-244-9825

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Manufactured in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

POLYETHYLENE GLYCOL, 3350 - 765 g - 45 Doses - Container Label [Front]

Container Label-Front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Instalax Polyethylene Glycol 3350 (765G) Container Label - Back

Back Label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0351672210434	GTIN-13: 0351672210434 EAN-13: 0351672210434 GTIN-12: 351672210434 UPC-A: 351672210434 GTIN storage (14 digits): 00351672210434	Instalax Polyethylene Glycol 3350 (765G) Container Label - Back.jpg
Data code	Data Matrix	5400		Instalax Polyethylene Glycol 3350 (765G) Container Label - Front.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2104-3	GM - Gram	51672-2104	1550d0e2-fe44-4a8b-bf24-23b2f52ca4ad	1	2025-12-16

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

Polyethylene Glycol 3350
InstaLax Polyethylene Glycol 3350

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-2104	51672-2104-3, 51672-2104-9, 51672-2104-5

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2025-11-18	full-release	2026-06-01 01:16:39

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203928-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2016-08-24
A203928-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2016-08-24

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`74a2ff9319b5…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polyethylene Glycol 3350	INSTALAX POLYETHYLENE GLYCOL 3350	Sun Pharmaceutical Industries, Inc.	40bd1be7-de67-8dff-e063-6294a90aca95	2026-07-24	Warnings	Exact identifier ndc (package): 51672-2104-5 ndc (package): 51672-2104-9 ndc (package): 51672-2104-3 ndc (product): 51672-2104 ndc11 (package): 51672210403 ndc11 (package): 51672210409 ndc11 (package): 51672210405 spl id: 5759d471-75fc-b607-e063-6394a90a058c spl set id: 40bd1be7-de67-8dff-e063-6294a90aca95

Reported adverse events (FAERS/openFDA)#

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