Label: POLYETHYLENE GLYCOL 3350 powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0489-1, 17856-0489-2, 17856-0489-3, 17856-0489-4, view more17856-0489-5, 17856-0489-6 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 57896-489
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 7, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each dose)
- Purpose
- 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.
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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
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct 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)
