Topcare ClearLax description, usages, side effects, indications, overdosage, supplying and lots more!

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Topcare ClearLax

Topco Associates LLC

Topco Associates LLC. ClearLax® Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each dose) (Pouches 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

Topcare ClearLax 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 (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 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

Topcare ClearLax 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?

1-888-423-0139

Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

ClearLax®

POLYETHYLENE GLYCOL 3350

POWDER FOR SOLUTION

OSMOTIC LAXATIVE

Relieves occasional constipation (irregularity)

Softens stool

COMPARE TO MIRALAX® active ingredient

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

ClearLax® Front Label ClearLax® Back Label Image 1 ClearLax® Back Label Image 2

Topcare ClearLax

Polyethylene Glycol 3350 POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-306
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 17 g

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-306-01 119 in 1 BOTTLE
2 NDC:36800-306-02 238 in 1 BOTTLE
3 NDC:36800-306-03 510 in 1 BOTTLE
4 NDC:36800-306-04 850 in 1 BOTTLE
5 17 in 1 POUCH
6 NDC:36800-306-19 595 in 1 BOTTLE

Marketing Information

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


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