Label: POLYETHYLENE GLYCOL 3350 powder, for solution
- NDC Code(s): 68001-607-55, 68001-607-69
- Packager: BluePoint Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 31, 2024
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- 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
Polyethylene glycol 3350 powder for oral solution 238g bottle label
Polyethylene glycol 3350 powder for oral solution 510g bottle label
Polythylene Glycol Powder 238g Label Page 1 Rev 012024
Polythylene Glycol Powder 238g Label Page 2 Rev 012024
Polythylene Glycol Powder 510g Label Page 1 Rev 012024
Polythylene Glycol Powder 510g Label Page 2 Rev 012024
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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:68001-607 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:68001-607-55 238 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 2 NDC:68001-607-69 510 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214990 10/01/2023 Labeler - BluePoint Laboratories (985523874) Establishment Name Address ID/FEI Business Operations Annora Pharma Private Limited 650980746 manufacture(68001-607)