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

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

Drug Label Information

Updated December 12, 2023

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

View All Sections
  • Active Ingredient (in each piece)

    Diphenhydrarnine HCI 25 mg

  • Purpose

    Nighttime Sleep Aid

  • Uses

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

  • Directions

    • Take only 1 dose per day (24 hours)
    • Chew each piece thoroughly before swallowing

    Dosage Chart

    Age (Years)Dose (Piece)
    Adults and children 12 years and over1 to 2 pieces (25 mg 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

    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.

  • Questions of 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)
    Registrant - CalmCo LLC (079308308)
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!