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NasalCrom (Prestige Brands Holdings, Inc.)

Available Formats

Dosage Form Package Information Links
SPRAY, METERED 1 BOTTLE, PUMP in 1 CARTON (52183-199-14) > 100 SPRAY, METERED in 1 BOTTLE, PUMP Label Information

Complete NasalCrom Information

  • SPL UNCLASSIFIED SECTION

    NasalCrom

    Drug Facts


  • Active ingredient (per spray)

    Cromolyn sodium 5.2mg


  • 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. (1-800-222-1222)


  • 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.
    • do not use if imprinted plastic bottle wrap is broken or missing
    • see bottom panel for lot number and expiration date

  • Inactive ingredients

    benzalkonium chloride, edetate disodium, purified water


  • Questions or comments?

    call 1-877-9-ALLERGY (1-877-925-5374)


  • Principal Display Panel

    NasalCrom

    cromolyn sodium nasal solution USP
    NASAL ALLERGY SYMPTOM CONTROLLER

    100 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

    0.44 FL OZ (13 mL)

    200 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

    0.88 FL OZ (26 mL)

    cromolyn sodium nasal solution USP
Nasal Spray
NasalCrom
NASAL ALLERGY SYMPTOM CONTROLLER
Presents and Relieves 
Nasal Allergy Symptoms
runny/itchy nose
Without Drowsiness
Full Prescription Strength
Safe for Ages 2 Years & older
100 Metered Sprays
Each spray delivers 
5.2 mg cromolyn sodium 0.44 FL AZ (13 mL)


  • INGREDIENTS AND APPEARANCE
    NASALCROM 
    cromolyn sodium spray, metered
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-199
    Route of Administration NASAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 5.2 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-199-14 1 in 1 CARTON 10/29/2009
    1 100 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2 NDC:52183-199-13 1 in 1 CARTON 10/29/2009
    2 200 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075702 10/29/2009
    Labeler - Prestige Brands Holdings, Inc. (159655021)