Label: AFRIN NODRIP ALLERGY SINUS NIGHT- oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 November 9, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    ▪ temporarily relieves nasal congestion due to:

    ▪ common cold ▪hay fever

    ▪ upper respiratory allergies

    ▪ reduces swelling of nasal passages so you can breathe more freely

    ▪ temporarily relieves sinus congestion and pressure

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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

    To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

  • OTHER SAFETY INFORMATION

    Other information

    ▪ store between 20º to 25ºC (68º to 77ºF)

    ▪ retain carton for future reference on full labeling

  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

  • QUESTIONS

    Questions or comments? 1-800-317-2165

  • Carton label 15 mL

    Oxymetazoline HCl

    Nasal Solution-Nasal Decongestant

    AFRIN

    NODRIP

    Wont drive from nose or down throat

    Allergy Sinus

    Night

    with soothing chamomile scent

    PUMP MIST

    Instant Congestion

    Relief from Allergies

    for a More Restful Night

    Reduces

    Swelling of

    Nasal

    Passages

    1/2 FL OZ (15mL)

    carton label

  • INGREDIENTS AND APPEARANCE
    AFRIN NODRIP ALLERGY SINUS NIGHT 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0034
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HIBISCUS BIFURCATUS WHOLE (UNII: 60F5JKG79P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0034-115 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/09/2020
    Labeler - Bayer HealthCare LLC. (112117283)