Label: NIGHTTIME SLEEP AID- diphenhydramine hcl 25 mg tablet, coated

  • NDC Code(s): 71679-110-03, 71679-110-06, 71679-110-10
  • Packager: Health Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • relief of occasional sleeplessness
  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    Ask a doctor before use if you have

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

    • heart disease

    Ask your doctor or pharmacist before use if you are

    • taking sedative or tranquilizers or any other sleep-aid

    When using this product

    • drowsiness will occur
    • avoid alcoholic beverages and other drugs that cause drowsiness
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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.

    Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed(see overdose warning)
    • adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor
    • children under 12 years of age:do not use
  • Other Information

    • Each caplet contains: Calcium 23.52 mg
    • store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
    • read all product information before using
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive Ingredients

    Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium,  Stearic Acid, Colloidal Silicon Dioxide, Magnesium Stearate, Film Coat AMB Blue, Polyethylene Glycol, Polyvinyl Alcohol, Brilliant Blue Lake, Indico Carmel Lake, Titanium dioxide, Talc

  • Questions or comments?

    Call 1-844-832-1138

    9AM – 5PM Monday-Friday

  • Principal Display Panel

    Diphenhydramine HCl 25 mg/Nighttime sleep-aid

    Compare to Tylenol ®Simply Sleep active ingredients*

    * This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep ®.

    label

    NDC 71679-110-10

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hcl 25 mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-110
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code S25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-110-03300 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
    2NDC:71679-110-06600 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
    3NDC:71679-110-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/01/2022
    Labeler - Health Pharma USA LLC (080804485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Pharma USA LLC080804485manufacture(71679-110)
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