Label: POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 83324-002-08, 83324-002-16
- Packager: CHAIN DRUG MARKETING ASSOCIATION, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 26, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each dose)
- Purpose
- Use
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
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Directions
• do not take more than directed unless advised by your doctor
• the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
• adults and children 17 years of age and older:• use once a day
• fill to top of white section in cap which is marked to indicate the correct dose (17 g)
• stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink• do not combine with starch-based thickeners used for difficult swallowing
• ensure that the powder is fully dissolved before drinking
• do not drink if there are any clumps
• do not use more than 7 days
• children 16 years of age or under: ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83324-002 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:83324-002-08 238 g in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2024 2 NDC:83324-002-16 510 g in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214990 03/01/2024 Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774) Establishment Name Address ID/FEI Business Operations Annora Pharma Private Limited 650980746 analysis(83324-002) , manufacture(83324-002)
