POLYETHYLENE GLYCOL 3350 powder, for solution

Polyethylene glycol 3350 by

Drug Labeling and Warnings

Polyethylene glycol 3350 by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. 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 need to use a laxative for longer than 1 week
• you get diarrhea

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 20º to 25ºC (68º to 77ºF)
• tamper-evident: do not use if foil is open or broken

Inactive ingredients

none

Questions or comments?

(800) 616-2471

Principal display panel

NDC: 0904-6931-76

Compare to MiraLAX® active ingredient*

MAJOR®

PEG3350

Polyethylene Glycol 3350
Powder for Oral Solution
Osmotic Laxative

Relieves Occasional Constipation (Irregularity)
Softens Stool

Dissolves in Any Beverage
Sugar Free

30 Once-Daily Doses
NET WT 0.5 OZ (17 g) Each

*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark MiraLAX®.

Rev. 04/19       M-17
Re-order No.        701067

50844      REV0219A72601

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

Product of India

Major 44-726

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6931
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

Product Characteristics
Color	WHITE (colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6931-81	100 in 1 CARTON	06/30/2019
1		17 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0904-6931-76	30 in 1 CARTON	06/30/2019
2		17 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0904-6931-26	14 in 1 CARTON	06/30/2019
3		17 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 0904-6931-86	17 g in 1 POUCH; Type 0: Not a Combination Product	06/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	06/30/2019

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0904-6931)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0904-6931)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0904-6931)