Label: POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-598-25 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0722-7116
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 1, 2010
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- Uses
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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.
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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
- Inactive ingredients
- Questions or Comments?
- Principal Display
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE
polyethylene glycol 3350, nf powder for solution, laxative powder, for solutionProduct 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