PEG 3350- polyethylene glycol 3350 powder, for solution 
Major Pharmaceuticals

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Major Pharmaceuticals PEG 3350 Drug Facts

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

peg3350 image
PEG 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6422-811700 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product03/04/201509/30/2021
2NDC:0904-6422-13510 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product03/04/201510/31/2021
3NDC:0904-6422-8514 in 1 CARTON10/29/201808/31/2021
317 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:0904-6422-8617 g in 1 PACKET; Type 0: Not a Combination Product10/29/201808/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068503/04/201510/31/2021
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2021
 
Major Pharmaceuticals