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Generic Name: polyethylene glycol 3350
Dosage Form: powder
Rite Aid Corporation Laxative Drug Facts
Active ingredient (in each dose) (Pouch Carton Only)
Polyethylene Glycol 3350, 17 g
Active ingredient (in each dose) (Bottle Only)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
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.
Directions (Pouch Carton Only)
do not take more than directed unless advised by your doctor
adults and children 17 years of age or 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 Carton 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
New! To-Go Pouches (Pouch Carton Only)
Compare to the active ingredient in MiraLAX®
Laxative
Polyethylene Glycol 3350
Powder for Solution, Laxative
Original Prescription Strength
Relieves Occasional Constipation
Softens Stool
# Once-Daily Doses
Laxative Carton
Laxative Bottle Label
LAXATIVE
polyethylene glycol 3350 powder
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
11822-0306
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)
POLYETHYLENE GLYCOL 3350
17 g in 17 g
Inactive Ingredients
Ingredient Name
Strength
No Inactive Ingredients Found
Product Characteristics
Color
WHITE
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
11822-0306-1
10 POUCH In 1 CARTON
contains a POUCH
1
17 g In 1 POUCH
This package is contained within the CARTON (11822-0306-1)
2
11822-0306-3
119 g In 1 BOTTLE
None
3
11822-0306-2
510 g In 1 BOTTLE
None
4
11822-0306-4
238 g In 1 BOTTLE
None
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA090685
10/13/2009
Labeler - Rite Aid Corporation (014578892)
Revised: 10/2009Rite Aid Corporation
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