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 Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g 

Purpose

Osmotic Laxative

Use

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 1 to 3 days

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

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

When using this product

you may have loose, watery, more frequent stools

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

If pregnant or breast-feeding,

ask health professional before use.

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)

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

Other information

• store at 20°- 25°C (68°– 77°F)
• tamper-evident: do not use if printed foil pouch is open or broken

Inactive ingredients

none

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to MiraLax® active ingredient

PEG 3350

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

Relieves Occasional Constipation (Irregularity)

Softens Stool

Unflavored Powder

Grit Free

30 Once-Daily Doses

30 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: 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: 0904-6422-81	1700 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	03/04/2015
2	NDC: 0904-6422-13	510 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	03/04/2015
3	NDC: 0904-6422-85	14 in 1 CARTON	10/29/2018
3		17 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0904-6422-86	17 g in 1 PACKET; Type 0: Not a Combination Product	10/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090685	03/04/2015

Labeler - Major Pharmaceuticals (191427277)