Label: ALLERGY RELIEF- chlorpheniramine maleate tablet

  • 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 February 15, 2013

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

View All Sections
  • Active ingredient (in each tablet)

    Chlorpheniramine Maleate 4mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves minor symptoms due to hay fever or other upper respiratory allergies such as:
      • sneezing
      • runny nose
      • itchy, watery eyes
      • itchy throat
  • Warnings


    Ask a doctor before use it you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urinating due to enlargement of the prostate gland
    • asthma, shortness of breath


  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

  • When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of accidental overdose get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years and over: Take one (1) tablet every 4 to 6 hours. Do not exceed 6 tablets in 24 hours.
    • Children 12 years and under: Consult a physician before use

  • Other information

    • store at 20° to 25°C (68°-67°F)
    • protect from excessive moisture
    • Do not exceed recommended dose
  • Inactive ingredients

    microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch glycolate, crospovidone, silicon dioxide, stearic acid, hypromellose, FDC red no.40, FDC yellow no.5, titanium dioxide, polyethyleneglycol, ethanol

  • Package label

    image of Allergy Relief carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0159
    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
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    ETHANETHIOL (UNII: M439R54A1D)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code BT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0159-22 in 1 BOX
    112 in 1 BLISTER PACK
    2NDC:67510-0159-02 in 1 BOX
    210 in 1 BLISTER PACK
    3NDC:67510-0159-44 in 1 BOX
    312 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/18/2011
    Labeler - Kareway Product, Inc. (121840057)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!