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ABSTRAL FENTANYL- fentanyl citrate tablet, orally disintegrating


  1. Patient Information
  2. Tablets When They Are No Longer Needed?
  3. When You Get An Episode Of Breakthrough Pain, Take The Dose Prescribed By Your Healthcare Provider As Follows:
  4. Revised: 10/2019document Id:

Patient Information 

Storage and Disposal of Unused and Used ABSTRAL[for proper disposal of ABSTRAL.

  • DO NOTdrive or operate heavy machinery, until you know how ABSTRAL affects you. ABSTRAL can make you sleepy, dizzy, or lightheaded.
  • DO NOTdrink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ABSTRALmay cause you to overdose and die.
  • DO NOT switch from ABSTRALto other medicines that contain fentanyl without talking with your healthcare provider.The amount of fentanyl in a dose of ABSTRALis not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRALthat may be different than other medicines containing fentanyl that you may have been taking.
  • How should I store ABSTRAL?

    • Always keep ABSTRALin a safe place away from children and from anyone for whom it has not been prescribed.Protect ABSTRALfrom theft.
    • Store ABSTRALat room temperature, 59 F to 86 F (15 C to 30 C) until ready to use.
    • Keep ABSTRALin the original blister unit. Do not remove ABSTRALtablets from their blister packaging for storage in a temporary container, such as a pillbox.

    How should I dispose of unopened ABSTRAL

    Tablets When They Are No Longer Needed? 

    • Dispose of expired, unwanted, or unused Abstral by removing the product from the blister cards and promptly flushing down the toilet (if a drug take-back option is not readily available). Visitwww.fda.gov/drugdisposalfor additional information on disposal of unused medicines.
    • Do not flush the ABSTRALblister cards, units, or cartons down the toilet.
    • If you need help with disposal of ABSTRAL, call 1-888-227-8725 or call your local Drug Enforcement Agency (DEA) office.

    General information about ABSTRAL

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.Use ABSTRALonly for the purpose for which it was prescribed. Do not give ABSTRALto other people, even if they have the same symptoms you have.ABSTRALcan harm other people and even cause death. Sharing ABSTRALis against the law.

    This Medication Guide summarizes the most important information about ABSTRAL. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about ABSTRALthat is written for healthcare professionals.

    For more information about the TIRF REMS Access program, go towww.TIRFREMSAccess.comor call 1- 866-822-1483.

    What are the ingredients in ABSTRAL?

    Active Ingredient: fentanyl citrate

    Inactive Ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose

    Patient Instructions for Use

    Before you take ABSTRAL, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that you read, understand, and follow these Patient Instructions for Use so that you take ABSTRALthe right way. Ask your healthcare provider or pharmacist if you have questions about the right way to take ABSTRAL.

    When You Get An Episode Of Breakthrough Pain, Take The Dose Prescribed By Your Healthcare Provider As Follows: 

    • If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water. Dry your hands if they are wet before you handle ABSTRALtablets.
    • ABSTRALcomes in a blister card with 4 blister units. Each blister unit contains an ABSTRALtablet. It is important that the tablet stays sealed in the blister unit until you are ready to use it.
    • When you are ready to take an ABSTRALtablet, pull apart 1 of the blister units from the blister card by tearing along the dotted lines (perforations) until it is fully separated (SeeFigures 1and2).
    Figure 1 Figure 2
    • When the blister unit is fully separated, peel back the foil starting at the unsealed area where indicated. Gently remove the tablet.Do nottry to push ABSTRALtablets through the foil. This will damage the tablet (SeeFigures 3and4).
    Figure 3 Figure 4
    • As soon as you remove the ABSTRALtablet from the blister unit:
      • Place it on the floor of your mouth, under your tongue, as far back as you can (SeeFigures 5,6, and7).
        Figure 5 Figure 6 Figure 7
      • If more than 1 tablet is required, spread them around the floor of your mouth under your tongue.
      • Let the tablet dissolve completely. ABSTRALdissolves under your tongue and will be absorbed by your body to help provide relief for your breakthrough cancer pain.
      • Do not suck, chew or swallow the tablet.
      • You should not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.

    Manufactured by:
    Pharmaceutics International, Inc. Hunt Valley, MD 21031

    Manufactured for:
    Sentynl Therapeutics, Inc. Solana Beach, CA 92075 Issued: October 2019

    This Medication Guide has been approved by the U.S. Food and Drug Administration.
    Copyright 2019, Sentynl Therapeutics, Inc. All rights reserved.

    ABSTRALand Sentynl Therapeutics, Inc. are trademarks owned by the Sentynl Therapeutics, Inc.

    Principal Display Panel - 100 mcg Carton Label

    ABSTRAL CII

    (fentanyl) sublingual tablets

    equivalent to 100 mcg fentanyl base

    NDC 42358-100-32 Rx only

    32 Sublingual Tablets

    (4 Tablets x 8 cards)

    Principal Display Panel - 100 mcg Carton Label

    Principal Display Panel - 200 mcg Carton Label

    ABSTRAL CII

    (fentanyl) sublingual tablets

    equivalent to 200 mcg fentanyl base

    NDC 42358-200-32 Rx only

    32 Sublingual Tablets

    (4 Tablets x 8 cards)

    Principal Display Panel - 200 mcg Carton Label

    Principal Display Panel - 300 mcg Carton Label

    ABSTRAL CII

    (fentanyl) sublingual tablets

    equivalent to 300 mcg fentanyl base

    NDC 42358-300-32 Rx only

    32 Sublingual Tablets

    (4 Tablets x 8 cards)

    Principal Display Panel - 300 mcg Carton Label

    Principal Display Panel - 400 mcg Carton Label

    ABSTRAL CII

    (fentanyl) sublingual tablets

    equivalent to 400 mcg fentanyl base

    NDC 42358-400-32 Rx only

    32 Sublingual Tablets

    (4 Tablets x 8 cards)

    Principal Display Panel - 400 mcg Carton Label

    Principal Display Panel - 600 mcg Carton Label

    ABSTRAL CII

    (fentanyl) sublingual tablets

    equivalent to 600 mcg fentanyl base

    NDC 42358-600-32 Rx only

    32 Sublingual Tablets

    (4 Tablets x 8 cards)

    Principal Display Panel - 600 mcg Carton Label

    Principal Display Panel - 800 mcg Carton Label

    ABSTRAL CII

    (fentanyl) sublingual tablets

    equivalent to 800 mcg fentanyl base

    NDC 42358-800-32 Rx only

    32 Sublingual Tablets

    (4 Tablets x 8 cards)

    Principal Display Panel - 800 mcg Carton Label
    ABSTRAL FENTANYL
    fentanyl citrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42358-100
    Route of AdministrationSUBLINGUALDEA ScheduleCII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl100 ug
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium(UNII: M28OL1HH48)
    magnesium stearate(UNII: 70097M6I30)
    mannitol(UNII: 3OWL53L36A)
    cellulose, microcrystalline(UNII: OP1R32D61U)
    Product Characteristics
    Colorwhite ( WHITE)Scoreno score
    ShapeROUND (ROUND)Size10mm
    FlavorImprint Code1
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42358-100-328 in 1 CARTON10/01/2016
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02251010/01/2016
    ABSTRAL FENTANYL
    fentanyl citrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42358-200
    Route of AdministrationSUBLINGUALDEA ScheduleCII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl200 ug
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium(UNII: M28OL1HH48)
    magnesium stearate(UNII: 70097M6I30)
    mannitol(UNII: 3OWL53L36A)
    cellulose, microcrystalline(UNII: OP1R32D61U)
    Product Characteristics
    Colorwhite ( WHITE)Scoreno score
    ShapeOVAL (OVAL)Size10mm
    FlavorImprint Code2
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42358-200-328 in 1 CARTON10/01/2016
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02251010/01/2016
    ABSTRAL FENTANYL
    fentanyl citrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42358-300
    Route of AdministrationSUBLINGUALDEA ScheduleCII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl300 ug
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium(UNII: M28OL1HH48)
    magnesium stearate(UNII: 70097M6I30)
    mannitol(UNII: 3OWL53L36A)
    cellulose, microcrystalline(UNII: OP1R32D61U)
    Product Characteristics
    Colorwhite ( WHITE)Scoreno score
    ShapeTRIANGLE (TRIANGLE)Size10mm
    FlavorImprint Code3
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42358-300-328 in 1 CARTON10/01/2016
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02251010/01/2016
    ABSTRAL FENTANYL
    fentanyl citrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42358-400
    Route of AdministrationSUBLINGUALDEA ScheduleCII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl400 ug
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium(UNII: M28OL1HH48)
    magnesium stearate(UNII: 70097M6I30)
    mannitol(UNII: 3OWL53L36A)
    cellulose, microcrystalline(UNII: OP1R32D61U)
    Product Characteristics
    Colorwhite ( WHITE)Scoreno score
    ShapeDIAMOND (DIAMOND)Size10mm
    FlavorImprint Code4
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42358-400-328 in 1 CARTON10/01/2016
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02251010/01/2016
    ABSTRAL FENTANYL
    fentanyl citrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42358-600
    Route of AdministrationSUBLINGUALDEA ScheduleCII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl600 ug
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium(UNII: M28OL1HH48)
    magnesium stearate(UNII: 70097M6I30)
    mannitol(UNII: 3OWL53L36A)
    cellulose, microcrystalline(UNII: OP1R32D61U)
    Product Characteristics
    Colorwhite ( WHITE)Scoreno score
    ShapeSEMI-CIRCLE (SEMI-CIRCLE (D--SHAPE))Size10mm
    FlavorImprint Code6
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42358-600-328 in 1 CARTON10/01/2016
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02251010/01/2016
    ABSTRAL FENTANYL
    fentanyl citrate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42358-800
    Route of AdministrationSUBLINGUALDEA ScheduleCII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fentanyl citrate(UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)fentanyl800 ug
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium(UNII: M28OL1HH48)
    magnesium stearate(UNII: 70097M6I30)
    mannitol(UNII: 3OWL53L36A)
    cellulose, microcrystalline(UNII: OP1R32D61U)
    Product Characteristics
    Colorwhite ( WHITE)Scoreno score
    ShapeCAPSULE (CAPSULE)Size10mm
    FlavorImprint Code8
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42358-800-328 in 1 CARTON10/01/2016
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02251010/01/2016
    Labeler -Sentynl Therapeutics, Inc. (078313706)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutics International, Inc.878265586MANUFACTURE(42358-100, 42358-200, 42358-300, 42358-400, 42358-600, 42358-800)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sharp Packaging Solutions143696495PACK(42358-100, 42358-200, 42358-300, 42358-400, 42358-600, 42358-800)

    Revised: 10/2019document Id: 

    a5edb551-b75b-4930-b557-1a3f1aa5115cSet id: e60f00e9-2cf4-4c20-b570-1c2ea426c8c7Version: 5Effective Time: 20191008Sentynl Therapeutics, Inc.



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