dulcolax balance

Dosage form: powder, for solution
Ingredients: POLYETHYLENE GLYCOL 3350 17g in 17g
Labeler: Boehringer Ingelheim Pharmaceuticals Inc
NDC Code: 0597-0015

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0015
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:0597-0015-333 POUCH (POUCH) in 1 CARTON
117 g in 1 POUCH
2NDC:0597-0015-13119 g in 1 BOTTLE
3NDC:0597-0015-14238 g in 1 BOTTLE
4NDC:0597-0015-15510 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068510/07/2009
Labeler - Boehringer Ingelheim Pharmaceuticals Inc (603175944)

Revised: 10/2009
 
Boehringer Ingelheim Pharmaceuticals Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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