Ez2gopeg 3350 powder

Inactive ingredient section

Inactive Ingredientsnone

Otc - active ingredient section

Active Ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Otc - purpose section

Purpose

Osmotic Laxative

Warnings section

Warnings

Allergy Alert:Do not use if you are allergic to polyethylene glycol

Do not useif you have kidney disease, except under the advice and supervision of a doctor

When using this product,you may have loose, watery, more frequent bowel movements

Otc - ask doctor section

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 useif you are taking a prescription drug


Otc - stop use section

Stop use and ask a doctor if

- you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse.These may be sogns of a serious condition.

- you get diarrhea

- you need to use a laxative for longer than 1 week

- side effects occur

Otc - keep out of reach of children section

Keep out of reach of children.In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding, ask a health professional before use.

Dosage & administration section

Directions

-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

-adults and children 17 years of age and older:

-fill to top of line 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) and then drink

-use once a day

-use no more than 7 days

-Children 16 years of age or under: ask a doctor



Otc - questions section

Questions or comments?

1-800-403-9832

Indications & usage section

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

Ingredients and appearance - Product information

Ez2gopeg 3350 powder- Polyethylene glycol 3350

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 76470-006
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)( Polyethylene glycol 3350 - UNII: G2M7P15E5P ) 17 gin 17 g

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 76470-006-06 238g in 1 BOTTLE 2012/10/20

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091077 USA 2012/10/20

Labeler - Valley Medical Products,LLC( 969389407)

Establishment

Name ID/FEI Business Operations
Valley Medical Products,LLC 969389407 manufacture( 76470-006)

Package label.principal display panel