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

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated September 14, 2023

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  • 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 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 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:

    NASAL SPRAY SEVERE NASAL CONGESTION RELIEF
  • INGREDIENTS AND APPEARANCE
    CVS SEVERE NASAL CONGESTION RELIEF  CLEAR AND COOL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-614
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-614-221 in 1 CARTON03/10/2022
    122 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/10/2022
    Labeler - CVS PHARMACY, INC. (062312574)
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