Gavilyte-h And Bisacodyl label

Gavilyte-h And Bisacodyl

Gavilyte-h And Bisacodyl Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

GaviLyte – H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

History

There is currently no drug history available for this drug.

Other Information


GaviLyte – H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte – H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP.

  • Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum lake and FD&C yellow # 6/sunset yellow FCF aluminum lake. The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte – H [see Dosage and Administration (2)].
  • GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin),  and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin). This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte – H solution is isosmotic, clear, and colorless. The GaviLyte – H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration (2)].

Gavilyte-h And Bisacodyl Manufacturers

  • Gavis Pharmaceuticals, Llc
    Gavilyte-h And Bisacodyl | Gavis Pharmaceuticals, Llc
    No Recall

    Gavilyte-h And Bisacodyl | Gavis Pharmaceuticals, Llc

    Gavilyte-h And Bisacodyl | Gavis Pharmaceuticals, Llc

    The recommended GaviLyte - H and bisacodyl delayed-release tablet, USP oral dosage regimen for adults on the day prior to colonoscopy is as follows:

    No solid food or milk (clear liquids only) should be consumed on the day of the preparation. Take one 5 mg bisacodyl delayed-release tablet, USP with water. Do NOT chew or crush the tablet. No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet, USP. Prepare the GaviLyte - H solution according to the instructions on the kit. Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) should be added to the solution. Prepare the GaviLyte - H solution by filling the container to the 2 liter mark with water. Cap the container. Shake to dissolve the powder. Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter GaviLyte - H solution at a rate of 8 ounces every 10 minutes. Drink all of the solution. If you have abdominal distention or discomfort, stop drinking the GaviLyte - H solution temporarily or drink each portion at longer intervals until your symptoms improve. Consume only clear liquids after taking the GaviLyte - H solution until your colonoscopy.