ALBUTEROL SULFATE solution

Albuterol Sulfate by

Drug Labeling and Warnings

Albuterol Sulfate by is a Prescription medication manufactured, distributed, or labeled by Cardinal Health 107, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Storage

PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F).

Rx only.

To report SUSPECTED ADVERSE REACTIONS, contact American Health Packaging at 1-800-707-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

  • SPL UNCLASSIFIED SECTION

    Manufactured by: The Ritedose Corporation, Columbia, SC 29203
    Distributed by: American Health Packaging, Columbus, OH 43217

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L58112600824

    RPIN0101
    September 2018

  • Patient's Instructions for Use

    Albuterol Sulfate Inhalation Solution 0.083%2
    Note: This is a unit-dose vial. No dilution is required.

    Read complete instructions carefully before using.

    • 1. Remove the vial from the foil pouch.
    • 2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).
    • 3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).
    • 4. Connect the nebulizer to the compressor.
    • 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) (or put on the face mask); and turn on the compressor.
    • 6. Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished.
    • 7. Clean the nebulizer (see manufacturer's instructions).
    Figures

    Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended.

    Store Albuterol Sulfate Inhalation Solution 0.083%2 between 2° and 25° C (36° and 77° F). Store in pouch until time of use.

    ADDITIONAL INSTRUCTIONS: ______________________________________________________________________________________

    To report SUSPECTED ADVERSE REACTIONS, contact American Health Packaging at 1-800-707-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    Manufactured by:
    The Ritedose Corporation
    Columbia, SC 29203

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L58112600824

    RPIN0101
    September 2018


  • 2 (Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate).
  • Package/Label Display Panel

    ALBUTEROL SULFATE INHALATION

    SOLUTION, 0.083%* 2.5 mg/3 mL*

    5 x 3 mL STERILE UNIT-DOSE VIALS

    EACH IN A FOIL POUCH

    2.5mg/3mL bag label
  • INGREDIENTS AND APPEARANCE
    ALBUTEROL SULFATE 
    albuterol sulfate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 55154-2132(NDC:60687-395)
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL2.5 mg  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SULFURIC ACID (UNII: O40UQP6WCF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 55154-2132-55 in 1 BAG01/16/2023
    11 in 1 POUCH
    13 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07783901/16/2023
    Labeler - Cardinal Health 107, LLC (118546603)

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