Label: GAVILAX- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 68788-7508-2
- Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 43386-312
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- WARNINGS
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of the reach of children
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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.
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- adults and children 17 years of age and older:
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- fill to top of line 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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- use once a day
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- use no more than 7 days
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- children 16 years of age or under: ask a doctor
Other Information
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- store at 20°- 25°C (68°– 77°F)
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- tamper-evident: do not use if printed foil seal under cap is missing, open or broken
- Inactive Ingredient
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GAVILAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7508(NDC:43386-312) 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 Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7508-2 238 g in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-7508)
