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 NUVO PHARMACEUTICAL INC., SUNRISE PHARMACEUTICAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)                     

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Uses

• 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 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
• the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (clear section in cap)
• adults and children 17 years of age and older:

  ○ fill to top of clear section in cap which is marked to indicate the correct dose (17 g)

  ○ stir and dissolve 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 foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken

INACTIVE INGREDIENT

None

Questions or comments?

1-800-FDA-1088

Distributed by:
Nuvo Pharmaceutical, Inc.
Rahway, NJ 07065

Manufactured by:
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065

PRINCIPAL DISPLAY PANEL-119 g per Bottle

NDC: 425756-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

• Relieves Occasional

  Constipation/Irregularity

• Softens Stool
• Dissolves in Any Beverage

  Unflavored Powder Grit Free

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

  

  PRINCIPAL DISPLAY PANEL -238 g per Bottle

  NDC: 425756-180-28

  Polyethylene Glycol

  3350

  Powder for Solution, Osmotic Laxative

• Relieves Occasional

  Constipation/Irregularity

• Softens Stool
• Dissolves in Any Beverage

  Unflavored Powder Grit Free

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

  

  PRINCIPAL DISPLAY PANEL -510 g per Bottle

  NDC: 425756-180-50

  Polyethylene Glycol

  3350

  Powder for Solution, Osmotic Laxative

• Relieves Occasional

  Constipation/Irregularity

• Softens Stool
• Dissolves in Any Beverage

• Unflavored Powder Grit Free

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

• 

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 NF 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42576-180
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: 42576-180-19	119 g in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2017
2	NDC: 42576-180-28	238 g in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2017
3	NDC: 42576-180-50	510 g in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206105	07/03/2017

Labeler - NUVO PHARMACEUTICAL INC. (078366708)

Registrant - NUVO PHARMACEUTICAL INC. (078366708)

Establishment
Name	Address	ID/FEI	Business Operations
SUNRISE PHARMACEUTICAL INC.		168522378	MANUFACTURE(42576-180) , ANALYSIS(42576-180) , PACK(42576-180)