DULCOLAX BALANCE- polyethylene glycol 3350 powder, for solution
Boehringer Ingelheim Pharmaceuticals Inc

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Boehringer-Ingelheim Consumer Health Care Products Dulcolax Balance® Drug Facts

Active ingredient (in each dose) (Pouches 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 (Pouches 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 or 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 (Pouches 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

about DULCOLAX BALANCE? 1-888-285-9159 (English/Spanish) or www.Dulcolax.com

Principal Display Panel

New! {currently appears on carton only}

Dulcolax Balance®

Polyethylene Glycol 3350

Powder for Solution, Laxative

Relieves Occasional Constipation

Softens Stool

# Once-Daily Doses {Replace "#" with the number of Daily Doses in the package}

Dulcolax Balance® Carton

Dulcolax Balance® Label

DULCOLAX BALANCE
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0597-0015
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:0597-0015-33	3 in 1 CARTON
1		17 g in 1 POUCH
2	NDC:0597-0015-13	119 g in 1 BOTTLE
3	NDC:0597-0015-14	238 g in 1 BOTTLE
4	NDC:0597-0015-15	510 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090685	10/07/2009

Labeler - Boehringer Ingelheim Pharmaceuticals Inc (603175944)

Revised: 10/2009

Document Id: 4e57b282-fc6c-4834-a66d-e787755e5712

Set id: 4e57b282-fc6c-4834-a66d-e787755e5712

Version: 1

Effective Time: 20091007

Boehringer Ingelheim Pharmaceuticals Inc