PEG 3350- polyethylene glycol 3350 powder, for solution

PEG 3350 by

Drug Labeling and Warnings

PEG 3350 by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

Inactive Ingredients   none

Active Ingredient

Active Ingredient (in each dose)

Polyethylene Glycol 3350, 17 gm each packet

Purpose

Purpose

Osmotic Laxative

Original Prescription Strength

Compare to Miralax®

-Relieves Occasional Constipation (irregularity)

-Softens Stool

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 bowel movements

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 signs of a serious condition.

- you get diarrhea

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

- side effects occur

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 Warning

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

Dosage and 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 (17 g) 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

Storage and Handling

Storage:

Store at 20-25C (68-77F)

Questions?

Questions or comments?

1-800-616-24710

Indications and Usage

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

Distributed By:

Major Pharmaceuticals

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L50719800519

Principal Display Panel

PEG3350

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

5 Packets – NET WT 0.5 oz (17 g) Each

INGREDIENTS AND APPEARANCE

PEG 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-6899(NDC:0904-6422)
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: 55154-6899-5	5 in 1 BAG	03/04/2015
1		17 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091077	03/04/2015

Labeler - Cardinal Health (603638201)