Label: GAVILAX- polyethylene glycol 3350 powder, for solution
17856-0312-4, view more17856-0312-5, 17856-0312-6
- Packager: ATLANTIC BIOLOGICALS CORP.
- 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 January 26, 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
- 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?
- GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION
INGREDIENTS AND APPEARANCE
polyethylene glycol 3350 powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0312(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:17856-0312-1 17 g in 1 BAG; Type 0: Not a Combination Product 01/26/2021 2 NDC:17856-0312-2 8.5 g in 1 BAG; Type 0: Not a Combination Product 01/26/2021 3 NDC:17856-0312-3 17 g in 1 CUP; Type 0: Not a Combination Product 01/26/2021 4 NDC:17856-0312-4 4 g in 1 BAG; Type 0: Not a Combination Product 01/26/2021 5 NDC:17856-0312-5 50 in 1 CASE 01/26/2021 5 8.5 g in 1 CUP; Type 0: Not a Combination Product 6 NDC:17856-0312-6 72 in 1 CASE 01/26/2021 6 4.5 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Registrant - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 RELABEL(17856-0312) , REPACK(17856-0312)