Label: CALMCO SLEEP AID GUMMY BITE- diphenhydramine hcl bar, chewable

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

Drug Label Information

Updated December 7, 2024

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  • Drug Facts

  • Active ingredient and Purpose

    Active ingredientPurpose
    Diphenhydramine HCl 25 mg ..................Nighttime sleep aid

  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

    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

    When using this product

    avoid alcoholic drinks

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

    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.

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • 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

    FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, 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.

  • Directions

    • take only 1 dose per day (24 hours)
    • chew each piece thoroughly before swallowing
    Age (Yrs)Dose (per piece)

    adults and children 12 years and over

    		1 to 2 pieces (25 mg to 50 mg)
    children under 12 yearsdo not use

  • Questions or Comments?

    Call 941-203-4590 or visit www.calmco.com

  • Principal Display Panel

    Sleep Aid PDPsleep aid peel back

  • INGREDIENTS AND APPEARANCE
    CALMCO SLEEP AID GUMMY BITE 
    diphenhydramine hcl bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-2518
    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
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTITOL (UNII: D65DG142WK)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    NEOTAME (UNII: VJ597D52EX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    ACACIA (UNII: 5C5403N26O)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeRECTANGLESize15mm
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-2518-125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01012/12/2023
    Labeler - CalmCo LLC (079308308)
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