EZ2GO- polyethylene glycol 3350 powder

EZ2go by

Drug Labeling and Warnings

EZ2go by is a Otc medication manufactured, distributed, or labeled by Valley Medical Products,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients   none

ACTIVE INGREDIENT

Active Ingredient

Polyethylene Glycol 3350, 17 g

PURPOSE

Purpose

Osmotic Laxative

WARNINGS

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

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

ASK 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

STOP USE

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 may occur. you may report the side effects

to FDA at 1 - 800 - FDA - 1088

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions

-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 (17g) 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

QUESTIONS

Questions or comments?

1-800-403-9832

INDICATIONS & USAGE

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EZ2GO  
polyethylene glycol 3350 powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76470-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 17 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76470-005-05	238 g in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2012
2	NDC: 76470-005-17	17 g in 1 POUCH; Type 0: Not a Combination Product	10/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091077	10/20/2012

Labeler - Valley Medical Products,LLC (969389407)

Establishment
Name	Address	ID/FEI	Business Operations
Novel Laboratories, Inc.		793518643	manufacture(76470-005)

Establishment
Name	Address	ID/FEI	Business Operations
Valley Medical Products,LLC		969389407	relabel(76470-005) , repack(76470-005)