LAXATIVE- polyethylene glycol 3350 powder 
Rite Aid Corporation

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Rite Aid Corporation Laxative Drug Facts

Active ingredient (in each dose) (Pouch Carton Only)

Polyethylene Glycol 3350, 17 g (in each pouch)

Active ingredient (in each dose) (Bottle Only)

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

Purpose

Osmotic Laxative

Uses

  • 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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions (Pouch Carton Only)

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
  • stir and dissolve one packet of powder (17 g) 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

Directions (Bottle Only)

  • 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 (white section in cap)
  • adults and children 17 years of age and older:
  • fill to top of white section 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 pouch is open or broken {pouch only}
  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken {bottle only}

Inactive ingredients

none

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in MiraLAX®

laxative

polyethylene glycol 3350

powder for solution

osmotic laxative

ORIGINAL PRESCRIPTION STRENGTH

relieves occasional constipation (irregularity)

softens stool

# ONCE-DAILY DOSES {Replace "#" with number of daily doses}

Laxative Front Label

Laxative Front Label

Laxative Back Label

Laxative Back Label

LAXATIVE 
polyethylene glycol 3350 powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-0306
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 DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0306-110 in 1 CARTON
117 g in 1 POUCH
2NDC:11822-0306-3119 g in 1 BOTTLE
3NDC:11822-0306-5510 g in 1 BOTTLE
4NDC:11822-0306-4238 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068510/09/2009
Labeler - Rite Aid Corporation (014578892)

Revised: 1/2012
Document Id: ddc3dc42-60fe-4832-8959-864a1d3b7bb8
Set id: 457f5d2d-4595-482a-9ffa-659fb5d5b134
Version: 3
Effective Time: 20120120
 
Rite Aid Corporation