Gavilax Powder, For Solution
FDA Label NDC 43386-312

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lupin Pharmaceuticals,inc. for the product Gavilax (NDC 43386-312). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of the reach of children, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 43386-312-08

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

NDC 43386-312-85

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

50 ONCE-DAILY DOSES

NET WT 29.9 OZ (850 g)

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