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4 Way

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Xylometazoline Hydrochloride

Purpose

Nasal decongestant

4 Way Uses

• temporarily relieves nasal congestion due to:

• a cold   • hay fever • upper respiratory allergies

• soothes nasal discomfort caused by dryness

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 8 to 10 hours children under 12 years of age: ask a doctor
  • do not use more than 3 doses in 24 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.

4 Way Other information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • container is filled to proper level for best spray action
  • non-USP for assay

Inactive Ingredients

benzalkonium chloride, dibasic sodium phosphate, edetate disodium, hypromellose, monobasic sodium phosphate, purified water, sodium chloride, sorbitol solution

Questions

1-800-452-0051

Distr. By: Novartis Consumer Health, Inc.

 Parsippany, NJ 07054-0622

Principal Display

4 Way

4 Way

Phenylephrine hydrochloride SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-2094
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
XYLOMETAZOLINE HYDROCHLORIDE XYLOMETAZOLINE 0.01 L

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
hypromellose
SODIUM CHLORIDE
sodium phosphate, monobasic
sorbitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 .0148 in 1 BOTTLE, SPRAY
2 NDC:0067-2094-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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