NASALCROM- cromolyn sodium spray, metered 
Prestige Brands Holdings, Inc.

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Drug Facts

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:

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

Other information

Inactive ingredients

benzalkonium chloride, edetate disodium, purified water

Questions or comments?

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

9226205

Principal Display Panel

NASAL SPRAY

NasalCrom ®

cromolyn sodium nasal solution, USP

NASAL ALLERGY

SYMPTOM CONTROLLER

PREVENTS
& RELIEVES

NASAL ALLERGY
SYMPTOMS

For Intranasal use only.

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

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 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:52183-199-131 in 1 CARTON10/29/2009
2200 in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
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)

Revised: 12/2023
Document Id: 0bc4526a-5d34-bb8a-e063-6394a90abfeb
Set id: b34d36ca-4df4-458c-af0f-c0d0c9a025d9
Version: 11
Effective Time: 20231205
 
Prestige Brands Holdings, Inc.