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

Drug Details [pdf]

SPL UNCLASSIFIED

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated line)

OTC - 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

OTC - DO NOT USE

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

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor of pharmacist before use if you are taking a prescription drug

OTC - WHEN USING

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

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of the 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 (white section in cap)
• adults and children 17 years of age and older:
  • fill to top of white 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° to 25°C (68° to 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

OTC - QUESTIONS

Questions or comments?

1-800-540-3765

Manufactured by

Gericare Pharmaceuticals

1650 63rd Street, Brooklyn, NY 11204

Product of India

Issued: 10/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 57896-490-30

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

• Relieves Occasional Constipation      (Irregularity)
• Softens Stool

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

• Dissolves in any beverage
• Sugar Free

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

510 g CAN

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-490
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: 57896-490-30	510 g in 1 CAN; Type 0: Not a Combination Product	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	05/21/2019

Labeler - Gericare Pharmaceuticals (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	ANALYSIS(57896-490) , MANUFACTURE(57896-490) , PACK(57896-490)