POLYETHYLENE GLYCOL 3350 NF- polyethylene glycol 3350 powder, for solution

POLYETHYLENE GLYCOL 3350 NF by

Drug Labeling and Warnings

POLYETHYLENE GLYCOL 3350 NF by is a Otc medication manufactured, distributed, or labeled by Woodward Pharma Services LLC, Future Pak, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

SPL UNCLASSIFIED SECTION

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 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 a 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.

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 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 ingredient

none

Questions or comments?

1-888-514-4727

PRINCIPAL DISPLAY PANEL

NDC: 69784-180-14

Original Prescription Strength

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

Relieves Occasional Constipation (irregularity)

Softens Stool

14 ct Unit-Dose Packets
0.5 OZ (17 gm) each

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 NF 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69784-180(NDC:11534-180)
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	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69784-180-14	14 in 1 CARTON	06/06/2018
1	NDC: 69784-180-01	17 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69784-180-30	30 in 1 CARTON	06/06/2018
2	NDC: 69784-180-01	17 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 69784-180-10	100 in 1 CARTON	06/06/2018
3	NDC: 69784-180-01	17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206105	06/06/2018

Labeler - Woodward Pharma Services LLC (026749066)

Registrant - Woodward Pharma Services LLC (026749066)

Establishment
Name	Address	ID/FEI	Business Operations
Future Pak, Ltd.		087737672	repack(69784-180)