Label: POLYETHYLENE GLYCOL 3350 powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0962-1, 17856-0962-2, 17856-0962-3, 17856-0962-4, view more17856-0962-5 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 51991-962
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose)
- Purpose
- Use
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Warnings
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
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Directions
- do not take more than directed unless advised by your doctor
- this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.
- adults and children 17 years of age and older:
- fill to the indicated "17 GRAMS" line on cup 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
- Ensure that the powder is fully dissolved before drinking.
- Do not drink if there are any clumps.
- 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 510 g Bottle 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:17856-0962(NDC:51991-962) 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:17856-0962-1 72 in 1 BOX, UNIT-DOSE 02/17/2021 1 4 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:17856-0962-2 72 in 1 BOX, UNIT-DOSE 02/17/2021 2 4.25 g in 1 POUCH; Type 0: Not a Combination Product 3 NDC:17856-0962-3 50 in 1 BOX, UNIT-DOSE 02/17/2021 3 8.50 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:17856-0962-4 72 in 1 BOX, UNIT-DOSE 02/17/2021 4 8.50 g in 1 POUCH; Type 0: Not a Combination Product 5 NDC:17856-0962-5 50 in 1 BOX, UNIT-DOSE 06/08/2021 5 4.25 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 03/27/2019 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 relabel(17856-0962) , repack(17856-0962)