Nasalcrom Spray, Metered
FDA Label NDC 52183-199

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Nasalcrom (NDC 52183-199). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per spray), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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)

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