4 WAY FAST ACTING- phenylephrine hydrochloride spray 
Novartis Consumer Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Phenylephrine hydrochloride

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:

• common cold   • hay fever • upper respiratory allergies

Warnings

Ask 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 use more than directed

• do not use more than 3 days

• use only as directed

• frequent or prolonged use may cause nasal congestion to recur or worsen

• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

• infection may spread if this container is used by more than one person

Stop use and ask a doctor if

symptoms persist

Pregnancy 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.

Directions

  • adults and children 12 years of age and over: 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 controlled room temperature 20°-25°C (68°-77°F)
  • container is filled to proper level for best spray action

Inactive Ingredients

benzalkonium chloride, boric acid, sodium borate, water

Questions

1-800-452-0051

Distr. By: Novartis Consumer Health, Inc.

 Parsippany, NJ 07054-0622

Principal Display

4 Way

4 WAY  FAST ACTING
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-2086
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.01 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
SODIUM BORATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2086-011 in 1 CARTON
1.0296 L in 1 BOTTLE, SPRAY
2NDC:0067-2086-051 in 1 CARTON
2.0148 L in 1 BOTTLE, SPRAY
3NDC:0067-2086-621 in 1 CARTON
3.0185 L in 1 BOTTLE, SPRAY
4NDC:0067-2086-151 in 1 CARTON
4.037 L in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2010
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 1/2010
 
Novartis Consumer Health, Inc.