Label: BERKLEY AND JENSEN CLEARLAX- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 68391-306-02, 68391-306-03
- Packager: BJWC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 12, 2023
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- 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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- fill to top of white section in cap which is marked to indicate the 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 the powder is fully dissolved before drinking
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- do not drink if there are any clumps
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- do not use 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
BERKLEY AND JENSEN CLEARLAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-306 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:68391-306-03 2 in 1 PACKAGE 12/17/2009 10/01/2019 1 510 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68391-306-02 765 g in 1 BOTTLE; Type 0: Not a Combination Product 01/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 12/17/2009 Labeler - BJWC (159082692)