Label: NASALCROM- cromolyn sodium spray, metered

  • NDC Code(s): 52183-199-13, 52183-199-14
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 3, 2021

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

  • Drug Facts

    NasalCrom® Nasal Spray:
    (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

    For external use only

    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 (1-800-222-1222) 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.
    see bottom panel for lot number and expiration date
  • Inactive ingredients

    benzalkonium chloride, edetate disodium, purified water

  • Questions or comments?

    Call toll-free 1-877-9-ALLERGY (1-877-925-5374)

  • Principal Display Panel

    NASAL SPRAY

    NasalCrom®

    cromolyn sodium nasal solution, USP

    NASAL ALLERGY

    SYMPTOM CONTROLLER

    PREVENTS
    & RELIEVES

    NASAL ALLERGY SYMPTOMS

    For Intranasal use only.

    runny / itchy nose
    sneezing
    allergic stuffy nose

    ORIGINAL PRESCRIPTION STRENGTH

    Safe for ages 2+

    200 METERED SPRAYS

    Each spray delivers 5.2 mg cromolyn sodium

    0.88 FL OZ (26 mL)carton

  • INGREDIENTS AND APPEARANCE
    NASALCROM 
    cromolyn sodium spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-199
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM5.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-199-141 in 1 CARTON10/29/2009
    1100 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:52183-199-131 in 1 CARTON10/29/2009
    2200 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07570210/29/2009
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch Health Companies Inc.245141858MANUFACTURE(52183-199)