GENTLE LAX - polyethylene glycol 3350 powder, for solution 
Kroger Company

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Kroger Co. GentleLax™ 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 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 (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?

1-800-632-6900

Principal Display Panel

To-Go Pouches (Pouches Only)

Compare to active ingredient of MiraLAX® - see back panel

GentleLax™

Polyethylene Glycol 3350

Powder for Solution, Laxative

Original Prescription Strength

Relieves Occasional Constipation

Softens Stool

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

GENTLE LAX  polyethylene glycol 3350   powder, for solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30142-306 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 30142-306-52 10 POUCH In 1 CARTON contains a POUCH (30142-306-00) 1 30142-306-00 17 g In 1 POUCH This package is contained within the CARTON (30142-306-52) 2 30142-306-03 510 g In 1 BOTTLE None 3 30142-306-01 119 g In 1 BOTTLE None 4 30142-306-02 238 g In 1 BOTTLE None

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

Labeler - Kroger Company (006999528)

Revised: 10/2009Kroger Company