PEG 3350- polyethylene glycol 3350 powder, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Osmotic Laxative Original Prescription Strength Compare to Miralax® active ingredient -Relieves Occasional Constipation (irregularity) -Softens Stool -Unflavored Powder -Grit Free -Gluten Free -Dissolves in any beverage -Sugar Free -Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. 5 Pre-Measured Single Doses Travel Size Packets 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 L54988781119 *This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of MiraLAX®
Authorization status:
Abbreviated New Drug Application
Authorization number:
55154-7982-5

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

Purpos e

Purpos e

Osmotic Laxative

Original Prescription Strength

Compare to Miralax® active ingredient

-Relieves Occasional Constipation (irregularity)

-Softens Stool

-Unflavored Powder

-Grit Free

-Gluten Free

-Dissolves in any beverage

-Sugar Free

-Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

5 Pre-Measured Single Doses Travel Size Packets

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

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. (1-800-222-1222)

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 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

Storage and Handling

Storage:

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

Tamper-evident: do not use if printed foil pouch is open or broken

Ques tions ?

Questions or comments?

1-800-719-9260

Indications and Usage

Us e

-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

L54988781119

*This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of MiraLAX®

Principal Display Panel

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

5 Once-Daily Dose Packets

Net Wt 0.5 OZ (17 gm) Each

PEG 3350

polyethylene glycol 3350 powder, for solution

Product Information

Cardinal Health

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55154-79 8 2(NDC:0 9 0 4-6 422)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 -

UNII:G2M7P15E5P)

POLYETHYLENE GLYCOL

3350

17 g

in 17 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55154-79 8 2-5

5 in 1 BAG

0 3/0 4/20 15

1

17 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 10 77

0 3/0 4/20 15

Labeler -

Cardinal Health (603638201)

Revised: 5/2020

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