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GAVILAX by Atlantic Biologicals Corps

Medically reviewed on July 2, 2018

Dosage form: powder, for solution
Ingredients: POLYETHYLENE GLYCOL 3350 17g in 17g
Labeler: Atlantic Biologicals Corps
NDC Code: 17856-0312

Drug Facts

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

GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION
GAVILAX  
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0312(NDC:43386-312)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:17856-0312-117 g in 1 BAG
2NDC:17856-0312-28.5 g in 1 BAG
3NDC:17856-0312-317 g in 1 CUP
4NDC:17856-0312-44 g in 1 BAG
5NDC:17856-0312-550 CUP in 1 CASE
58.5 g in 1 CUP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107710/09/2009
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIOperations
Atlantic Biologicals Corps047437707RELABEL(17856-0312), REPACK(17856-0312)

 
Atlantic Biologicals Corps

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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