AVON HeXashield Congestion Relief Original: Package Insert and Label Information

AVON HEXASHIELD CONGESTION RELIEF ORIGINAL- oxymetazoline hydrochloride spray
Tai Guk Pharm. Co., Ltd.

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.

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to:

— common cold — hay fever

— upper respiratory allergies

  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

For external use only.

Ask a doctor before use if you have

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

When using this product

  • do not use more than directed
  • do not use for 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.
  • use of this container by more than one person may spread infection.

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.

Directions

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor: Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

Other information

  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Inactive Ingredients

benzalkonium chloride, edetate disodium, polyethylene glycol 400, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasi dihydrate, water

Questions or comments?

Call toll free 1-800-FOR-AVON

www.avon.com

Principal Display Panel

HeXasheild

ORIGINAL

NASAL RELIEF SPRAY

CONGESTION RELIEF

Oxymetazoline HCl-

Nasal Decongestant

Compare to the active ingredient in Afrin ® Original

Rapid & Powerful Congestion

Relief 12 Hour Relief

AVON

  • Original Nasal Spray — 12 HOURS
  • Pump Mist
  • Anti-Drip

NET WT 0.5 FL oz (15 mL)

AVON NASAL RELIEF SPRAY
(click image for full-size original)
AVON HEXASHIELD CONGESTION RELIEF ORIGINAL
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-105
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POVIDONE
SODIUM PHOSPHATE, DIBASIC
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
EDETATE DISODIUM (EDETIC ACID)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43136-105-01 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 15 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (43136-105-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/31/2019
Labeler — Tai Guk Pharm. Co., Ltd. (689060246)
Establishment
Name Address ID/FEI Operations
Tai Guk Pharma. Co., Ltd. 689060246 manufacture (43136-105)

Revised: 07/2019 Tai Guk Pharm. Co., Ltd.

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