Label: MEIJER MULTI-SYMPTOM RELIEF- polyethylene glycol, tetrahydrozoline hydrochloride, zinc sulfate solution/ drops

  • NDC Code(s): 55651-250-01
  • Packager: K.C. Pharmaceuticals, Inc.
  • 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 January 6, 2023

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

  • DRUG FACTS

    Active ingredients

    Polyethylene glycol 400 ........1%

    Tetrahydrozoline HCl.............0.05%

    Zinc sulfate............................0.25%

    Purposes

    Polyethylene glycol 400 .....Lubricant

    Tetrahydrozoline HCl...........Redness reliever

    Zinc sulfate..........................Astringent

  • INDICATIONS & USAGE

    Uses

    • relieves dryness of the eye
    • for temporary relief of discomfort and redness of the eye due to minor eye irritations
    • for temporary relief of burning and irritation due to exposure to wind or sun
    • for protection against further irritation
  • WARNINGS

    Warnings

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after using
    • do not use if this solution changes color or becomes cloudy

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours

    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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Instill 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • some users may experience a brief tingling sensation
    • store at 20-25°C (68-77ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate

  • QUESTIONS

    Questions or comments?

    Call 1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    MEIJER MULTI-SYMPTOM RELIEF 
    polyethylene glycol, tetrahydrozoline hydrochloride, zinc sulfate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-250
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BORIC ACID (UNII: R57ZHV85D4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55651-250-011 in 1 CARTON01/09/2023
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/09/2023
    Labeler - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(55651-250) , pack(55651-250) , label(55651-250)