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 ATLANTIC BIOLOGICALS CORP., ATLANTIC BIOLOGICALS CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

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

Purpose

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

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 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 cap is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
• adults and children 17 years of age and older:
• fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
• 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 younger: 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 ingredients

none

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16 TH PLACE 

MIAMI, FL 33179

For serious adverse events call:

1-888-710-0006

Package label

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0489(NDC:57896-489)
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: 17856-0489-1	50 in 1 BOX, UNIT-DOSE	08/07/2018
1		17 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-0489-2	72 in 1 BOX, UNIT-DOSE	08/07/2018
2		17 g in 1 BAG; Type 0: Not a Combination Product
3	NDC: 17856-0489-3	72 in 1 BOX, UNIT-DOSE	08/07/2018
3		4 g in 1 BAG; Type 0: Not a Combination Product
4	NDC: 17856-0489-4	72 in 1 BOX, UNIT-DOSE	08/07/2018
4		4.25 g in 1 BAG; Type 0: Not a Combination Product
5	NDC: 17856-0489-5	50 in 1 BOX, UNIT-DOSE	08/07/2018
5		8.5 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6	NDC: 17856-0489-6	72 in 1 BOX, UNIT-DOSE	08/07/2018
6		8.5 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	08/07/2018

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP		047437707	relabel(17856-0489) , repack(17856-0489)