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  5. Label Information: Gavilax

FDA Label for Gavilax

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. WARNINGS
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. STOP USE AND ASK A DOCTOR IF
    6. KEEP OUT OF THE REACH OF CHILDREN
    7. DIRECTIONS
    8. INACTIVE INGREDIENT
    9. QUESTIONS OR COMMENTS?
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gavilax Product Label

The following document was submitted to the FDA by the labeler of this product Lupin Pharmaceuticals,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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