Label: POLYETHYLENE GLYCOL 3350 powder, for solution
- NDC Code(s): 72657-196-16
- Packager: GLENMARK THERAPEUTICS INC., USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 2, 2024
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- Polyethylene Glycol 3350, Powder for Solution
- Active ingredient (in each dose) (Can only)
- Purpose
- Active ingredient (in each dose) (Packet Only)
- Purpose
- Use
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Warnings
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 (Can Only)
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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:
- o
- use once a day
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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
Directions (Packet Only)
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- do not take more than directed unless advised by your doctor
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- adults and children 17 years of age and older:
- o
- use once a day
- o
- stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- o
- do not combine with starch-based thickeners used for difficulty swallowing
- o
- ensure that the powder is fully dissolved before drinking
- o
- do not drink if there are any clumps
- o
- do not use more than 7 days
- •
- children 16 years of age or under: ask a doctor
- Other Information
- Inactive ingredients
- Questions or comments?
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 72657-196-16Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
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- Relieves Occasional Constipation (Irregularity)
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- Softens Stool
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- TAMPER-EVIDENT: do not use if printed foil seal under cap is missing, open or brokenUnflavoredf
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- Sugar Free
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- Dissolves in Any Beverage
45 ONCE-DAILY DOSES
NET WT 26.9 OZ (765 g) EACH
45s Label front
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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:72657-196 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 (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72657-196-16 765 g in 1 CAN; Type 0: Not a Combination Product 09/19/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203928 09/19/2024 Labeler - GLENMARK THERAPEUTICS INC., USA (969085666) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 918513263 ANALYSIS(72657-196) , MANUFACTURE(72657-196) , PACK(72657-196)
