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FDA LABEL GENERIC: Polyethylene Glycol 3350 MFR: Lupin Pharmaceuticals,Inc.

Gavilax 17 Gm Powder For Oral Solution

Table of Contents

Active Ingredient

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

Purpose

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: use once a day 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 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

store at 20°- 25°C (68°– 77°F) tamper-evident: do not use if printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredient

none

Questions or comments?

1-866-403-7592

Dissolves in any beverages Sugar Free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43386-312-08

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral 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 Oral Solution, Osmotic Laxative

50 ONCE-DAILY DOSES

NET WT 29.9 OZ (850 g)

NDC 43386-312-07

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)

NDC 43386-312-14

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)