QUALITY CHOICE- phenylephrine hydrochloride solution/ drops

Quality Choice by

Drug Labeling and Warnings

Quality Choice by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant

Uses

for the temporarily relief nasal congestion due to:

• common cold
• hay fever
• upper respiratory allergies

Warnings

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 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 (1-800-222-1222).

Directions

• adults and children 12 years of age and older: 2 or 3 drops 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

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC# 63868-697-30

*Compare to Active Ingredient in 4-Way® Fast Acting Nasal Spray

Nasal Spray

Nasal Decongestant

PHENYLEPHRINE HCl 1%

For Relief of:

Nasal Congestion

Sinus Congestion

Sinus Pressure

Swollen Nasal Membranes

100% QC SATISFACTION GUARANTEED

1 FL OZ (30 mL)

Distributed by: C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Novartis Consumer Health, Inc. the owner of the registered trademark 4-Way® Fast Acting Nasal Spray.

INGREDIENTS AND APPEARANCE

QUALITY CHOICE 
phenylephrine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-697
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-697-30	1 in 1 CARTON	12/18/2018
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/18/2018

Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)