Label: GAVILAX- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 50090-5310-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 43386-312
- Category: HUMAN OTC DRUG LABEL
Updated April 15, 2021
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- Active Ingredient
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of the reach of children
- 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.
- adults and children 17 years of age and older:
- fill to top of line 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
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any lumps
- use once a day
- use no more than 7 days
- children 16 years of age or under: ask a doctor
- store at 20°- 25°C (68°– 77°F)
- tamper-evident: do not use if printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
- Inactive Ingredient
- Questions or comments?
- Polyethylene Glycol 3350
INGREDIENTS AND APPEARANCE
polyethylene glycol 3350 powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5310(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:50090-5310-0 238 g in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5310)