Label: ADULT ALLERGY RELIEF- calmco allergy relief bar, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • Active Ingredient (in each piece)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ■ runny nose
    ■ itchy, watery eyes
    ■ sneezing
    ■ itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
    ■ runny nose
    ■ sneezing

  • WARNINGS

    Do not use


    • To make child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    When Using this product

    • marked drowsiness may occur
    • 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

    Ask A Doctor Before Use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    • chew each piece thoroughly before swallowing

    Dosage Chart

    Age (yr)Dose (piece)
    Adults and children 12 years and older1 to 2 pieces (25 to 50 mg)
    Children under 12 yearsDo not use

  • Other Information

    • each piece: contains sodium 9 mg.
    low sodium
    • store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container; do not use if printed seal under cap is broken or missing.

  • Inactive Ingredients

    Inactive ingredients: FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum atabic,
    hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene
    glycol, purified water, seaweed extract ( carrageenan), sodium chloride, starch, sucralose, sucrose,
    trisodium citrate dihydrate.

  • Questions or Comments

    Call 941-203-4590 or visit calmco.com

  • Package- outer label

    PDPpeel back

  • INGREDIENTS AND APPEARANCE
    ADULT ALLERGY RELIEF 
    calmco allergy relief bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-2520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    NEOTAME (UNII: VJ597D52EX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTITOL (UNII: D65DG142WK)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    ACACIA (UNII: 5C5403N26O)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeRECTANGLESize15mm
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-2520-120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/20/2023
    Labeler - CalmCo (079308308)
    Registrant - CalmCo (079308308)
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