Label: GAVILAX powder, for solution
- NDC Code(s): 61919-542-51
- Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 43386-312
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- purpose
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WARNINGS SECTION
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Allergy alert: Do not use if you are allergic to polyethylene glycol
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Close
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- OTC - ASK DOCTOR SECTION
- OTC - STOP USE SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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DOSAGE & ADMINISTRATION SECTION
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- 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
Other Information
- store at 20°- 25°C (68°– 77°F)
- tamper-evident: do not use if printed foil seal under cap is missing, open or broken
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GAVILAX
gavilax powder, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-542(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 Product Characteristics Color white (white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-542-51 510 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 01/01/2015 Labeler - DirectRX (079254320) Establishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-542)