PEG 3350- polyethylene glycol 3350 powder, for solution 
Cardinal Health

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Drug Facts

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

Bag Label
PEG 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6899(NDC:0904-6422)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6899-55 in 1 BAG03/04/201505/31/2021
117 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107703/04/201505/31/2021
Labeler - Cardinal Health (603638201)

Revised: 10/2020
 
Cardinal Health