Label: SPRINSOL- chlorpheniramine maleate tablet

  • NDC Code(s): 51467-101-01, 51467-101-02
  • Packager: FORTUNE PHARMACAL COMPANY LIMITED
  • 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 September 22, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Chlorpheniramine maleate 4 mg

  • PURPOSE

    Purpose
    Antihistamine

  • INDICATIONS & USAGE

    Uses
    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    sneezing
    runny nose
    itching of the nose or throat
    itchy, watery eyes

  • WARNINGS

    Warnings
    Ask a doctor before use if you have
    a breathing problem such as emphysema or chronic bronchitis
    glaucoma
    difficulty in urination due to enlargement of the prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    taking sedatives or tranquilizers

  • WHEN USING

    When using this product
    do not exceed recommended dosage unless directed by a physician
    may cause excitability especially in children
    use caution when driving or operating machinery
    avoid alcoholic beverages
    may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor
    children under 12 years of age: consult a doctor

  • OTHER SAFETY INFORMATION

    Other information
    keep tightly sealed
    protect from light
    store between 20 to 25 C (68 to 77 F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    Sprinsol

    Safely Sealed

    NDC 51467-101-02

    Chlorpheniramine maleate - Antihistamine

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    sneezing
    runny nose
    itching of the nose or throat
    itchy, watery eyes

    36 Tablets

    In Individually Sealed Strip

    Respiratory Series
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    SPRINSOL 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code FORTUNE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-101-012 in 1 BOX09/22/2017
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51467-101-023 in 1 BOX09/22/2017
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/22/2017
    Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-101)