GAVILAX description, usages, side effects, indications, overdosage, supplying and lots more!

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GAVILAX

Preferred Pharmaceuticals, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

1-866-403-7592

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC - 68788-9849-2
Original Prescription Strength
GaviLax
Polyethylene Glycol 3350
Powder for Solution, Osmotic Laxative
14 ONCE-DAILY DOSES
NET WT 8.3 OZ (238 g)

GAVILAX

Polyethylene Glycol 3350 POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9849(NDC:43386-312)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 17 g

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9849-2 238 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091077 2012-03-29


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Be sure to consult your doctor before taking any medication!
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