Label: GAVILAX- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 63187-368-23
- Packager: Proficient Rx LP
- 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
Updated June 1, 2022
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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
- 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 is missing, open or broken
- Inactive Ingredient
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
polyethylene glycol 3350 powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-368(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:63187-368-23 238 g in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-368) , RELABEL(63187-368)