FDA Label for Dollar General

View Indications, Usage & Precautions

Dollar General Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, Inc. (dollar General & Rexall). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Phenylephrine hydrochloride 1%


Purpose



Nasal decongestant


Uses



for the temporary relief of nasal congestion due to:

  • ▪common cold
  • ▪hay fever
  • ▪upper respiratory allergies

Ask A Doctor Before Use If You Have



  • ▪heart disease
  • ▪high blood pressure
  • ▪thyroid disease
  • ▪diabetes
  • ▪trouble urinating due to an enlarged prostate gland

When Using This Product



  • do not exceed recommended dosage
  • ▪do not use for more than 3 days. Use only as directed.
  • ▪temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • ▪the use of this container by more than one person may spread infection
  • ▪frequent or prolonged use may cause nasal congestion to recur or worsen

Stop Use And Ask A Doctor If



symptoms persist.


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 at 1-800-222-1222.


Directions



  • adults and children 12 years of age & older: 2 or 3 sprays in each nostril not more often than every 4 hours
  • children under 12 years of age: ask a doctor
  • ▪Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other Information



  • ▪store at room temperature
  • ▪container is filled to proper level for best spray action

Inactive Ingredients



benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate


Principal Display Panel



NDC 55910-827-30

Since 1903

Rexall®

Nasal Spray

Nasal Decongestant

Phenylephrine Hydrochloride 1 %

Fast Acting Relief of:

  • •Nasal congestion
  • •Sinus congestion
  • •Sinus pressure
  • •Swollen nasal membranes
  • 1 FL OZ (30mL)

    DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

    Visit us at: Rexall.com

    PACKAGED FOR DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072 USA

    IMPORTANT: Keep this carton for future reference on full labeling.


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