POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution

Polyethylene Glycol 3350, NF Powder for Solution, Laxative by

Drug Labeling and Warnings

Polyethylene Glycol 3350, NF Powder for Solution, Laxative by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Polyethylene Glycol 3350, 17g (cap filled to the top)

Purpose

Laxative

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

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 top is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
• adults and children 17 years of age and older
  • fill to the top of the bottle cap which will provide 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 younger, ask a doctor

Other Information

• Store at 20O - 25O C (68O - 77O 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

Questions or Comments?

For serious adverse events call: 

1-888-710-0006

Principal Display

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE 
polyethylene glycol 3350, nf powder for solution, laxative powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-598(NDC:0722-7116)
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 1 g

Inactive Ingredients
Ingredient Name	Strength
AIR (UNII: K21NZZ5Y0B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-598-25	255 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	10/07/2009

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK