CVS SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL- oxymetazoline hydrochloride spray

CVS Severe Nasal Congestion Relief by

Drug Labeling and Warnings

CVS Severe Nasal Congestion Relief by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:
  • a cold
  • hay fever or other upper respiratory allergies
• promotes nasal and sinus drainage
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages; shrinks swollen membranes

Warnings

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

When using this product

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

Stop use and ask a doctor ifsymptoms 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 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:consult a doctor.

Shake well before use.

To open:Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using for the first time, prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

DO NOT DISCARD CAP.

Other information

• store at room temperature

Inactive ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

*Compare to the active ingredient in Mucinex® SINUS-MAX® CLEAR & COOL Nasal Spray

NDC: 69842-614-22

NASAL SPRAY
Oxymetazoline HCl 0.05%
Nasal Decongestant

SEVERE NASAL CONGESTION RELIEF

CLEAR & COOL

• Fast acting
• Lasts 12 Hours
• Cooling Menthol
  flavor

3/4 FL OZ (22 mL)

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

Distributed By:

INGREDIENTS AND APPEARANCE

CVS SEVERE NASAL CONGESTION RELIEF   CLEAR AND COOL
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-614
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-614-22	1 in 1 CARTON	03/10/2022
1		22 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/10/2022

Labeler - CVS PHARMACY, INC. (062312574)