Instalax Tm

Instalax Tm
SPL v2
SPL
SPL Set ID 40bd1be7-de67-8dff-e063-6294a90aca95
Route
ORAL
Published
Effective Date 2025-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2025-10-09

Description

Drug Facts

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Drug Facts

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Manufactured in India

Section 50565-1

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

Section 50566-9

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
Section 50567-7

When using this product you may have loose, watery, more frequent stools

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug

Section 50569-3

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
Section 50570-1

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

Section 51945-4

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

Section 53414-9

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

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 (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
Allergy Alert:

Do not use if you are allergic to polyethylene glycol

Other Information
  • 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

none

Questions Or Comments?

1-877-244-9825

Active Ingredient (in Each Dose)

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

Package Label.principal Display Panel

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

Polyethylene Glycol 3350, Powder for Solution

Drug Facts


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5 (42229-5)

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Manufactured in India

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product you may have loose, watery, more frequent stools

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

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

Purpose

Osmotic Laxative

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 (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
Allergy Alert: (Allergy alert:)

Do not use if you are allergic to polyethylene glycol

Other Information
  • 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 ingredients)

none

Questions Or Comments? (Questions or comments?)

1-877-244-9825

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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

Polyethylene Glycol 3350, Powder for Solution

Drug Facts


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)