Label: CROMOLYN SODIUM spray, metered

  • NDC Code(s): 57782-397-26
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 19, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

     

    (Adults and children 2 years and older)

  • Active ingredient (per spray)

    Cromolyn sodium 5.2 mg

  • Purpose

    Nasal allergy symptom controller

  • Uses

    to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

    runny/itchy nose
    sneezing
    allergic stuffy nose
  • Warnings

    Do not use

    if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    fever
    discolored nasal discharge
    sinus pain
    wheezing

    When using this product

    it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
    brief stinging or sneezing may occur right after use
    do not use it to treat sinus infection, asthma, or cold symptoms
    do not share this bottle with anyone else as this may spread germs

    Stop use and ask a doctor if

    shortness of breath, wheezing, or chest tightness occurs
    hives or swelling of the mouth or throat occurs
    your symptoms worsen
    you have new symptoms
    your symptoms do not begin to improve within two weeks
    you need to use for more than 12 weeks

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    see package insert on how to use pump
    parent or care provider must supervise the use of this product by young children
    adults and children 2 years and older:
    spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.
    use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)
    to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.
    if desired, you can use this product with other medicines, including other allergy medicines.
    Children under 2 years: Do not use unless directed by a doctor.
  • Other information

    store between 20°– 25°C (68°– 77°F)
    protect from light
    keep carton and package insert. They contain important instructions.
  • Inactive ingredients

    benzalkonium chloride, edetate disodium, purified water

  • Questions?

    call toll-free 1-800-323-0000

  • Package/Label Principal Display Panel

    Cromoly Sodium Nasal Solution USP Carton

    HealthGuard

    NDC 57782-397-26

    Cromolyn Sodium Nasal Solution USP

    NASAL SPRAY

    Nasal Allergy Symptom Controller

    Prevents and Relieves Nasal Allergy Symptoms:
    runny/itchy nose
    sneezing
    allergic stuffy nose

    Without Drowsiness

    Full Prescription Strength

    Safe For Ages 2 Years & Older

    200 Metered Sprays

    Each spray delivers 5.2 mg cromolyn sodium

    0.88 FL OZ (26 mL)

  • INGREDIENTS AND APPEARANCE
    CROMOLYN SODIUM 
    cromolyn sodium spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57782-397
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM5.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57782-397-261 in 1 CARTON07/03/2001
    126 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07570207/03/2001
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(57782-397)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cambrex Profarmaco Milano Srl438051401API MANUFACTURE(57782-397)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aventis Pharma Manufacturing Pte LTD.595299306API MANUFACTURE(57782-397)