Label: PURELAX- polyethylene glycol 3350 powder, for solution
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NDC Code(s):
59779-306-01,
59779-306-02,
59779-306-03,
59779-306-04, view more59779-306-17, 59779-306-18, 59779-306-19, 59779-306-52, 59779-306-53, 59779-306-60
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 22, 2023
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
- Use
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Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol
Ask a doctor before use if you have
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- nausea, vomiting or abdominal pain
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- a sudden change in bowel habits that lasts over 2 weeks
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- irritable bowel syndrome
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Directions
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- do not take more than directed unless advised by your doctor
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- the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
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- adults and children 17 years of age and older:
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- use once a day
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- fill to top of white section in cap which is marked to indicate correct dose (17 g)
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- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
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- do not combine with starch-based thickeners used for difficulty swallowing
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- ensure that powder is fully dissolved before drinking
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- do no drink if there are any clumps
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- do not use no more than 7 days
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- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PURELAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-306 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:59779-306-01 119 g in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2009 2 NDC:59779-306-02 238 g in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2009 3 NDC:59779-306-03 510 g in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2009 4 NDC:59779-306-04 850 g in 1 BOTTLE; Type 0: Not a Combination Product 03/29/2011 5 NDC:59779-306-53 12 in 1 CARTON 10/14/2009 01/02/2016 5 17 g in 1 POUCH; Type 0: Not a Combination Product 6 NDC:59779-306-18 153 g in 1 BOTTLE; Type 0: Not a Combination Product 04/23/2014 06/15/2016 7 NDC:59779-306-17 289 g in 1 BOTTLE; Type 0: Not a Combination Product 02/11/2014 02/11/2014 8 NDC:59779-306-19 595 g in 1 BOTTLE; Type 0: Not a Combination Product 04/23/2014 03/31/2021 9 NDC:59779-306-52 10 in 1 CARTON 04/24/2015 9 17 g in 1 POUCH; Type 0: Not a Combination Product 10 NDC:59779-306-60 20 in 1 CARTON 05/05/2020 10 17 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 10/07/2009 Labeler - CVS Pharmacy (062312574)