Label: NIGHTTIME SLEEP-AID NON-HABIT FORMING- diphenhydramine hci liquid

  • NDC Code(s): 76281-522-24, 76281-522-25, 76281-522-28
  • Packager: AptaPharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each 30 mL dose cup or 2 tablespoons)
    Diphenhydramine HCI 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    ■ reduces time to fall asleep if you have difficulty falling asleep
    ■ for 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 any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

  • Ask a doctor before use if you have

    ■ heart disease
    ■ trouble urinating due to enlarged prostrate gland
    ■ glaucoma
    ■ a breathing problem such as asthma, emphysema or chronic bronchitis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking
    sedatives or tranquilizers or any other sleep aid

  • When using this product

    ■ do not use more than directed
    ■ avoid alcoholic beverages and other drugs that cause drowsiness
    ■ drowsiness will occur
    ■ be careful when driving a motor vehicle or operating machinery
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

  • Stop use and ask a doctor if

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help
    or contact a Poison Control Center right away.

  • Directions

    ■ take only as recommended
    ■ Use dosage cup or tablespoon

           Age                                     Dose
    Adults & children 12          One Dose = 2 tablespoons (30 mL) at bed
    years & over                    time if needed or as directed by a doctor

  • Other information

    ■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg
    ■ dosage cup provided
    ■ store at room temperature

  • Inactive ingredients

    citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn
    syrup, poloxamer 407, propylene glycol, purified water, sodium
    benzoate, sodium citrate, sodium saccharin

  • QUESTIONS

    Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
    1-877-798-5944

  • Nighttime Sleep-Aid Label

    NDC 76281-522-28

    AP SAFE

    *COMPARE TO the
    active ingredient in ZzzQUIL™
    NIGHTTIME SLEEP-AID

    Nighttime
    Sleep-Aid

    Diphenhydramine HCI

    Non-Habit Forming
    Not for treating Cold or Flu

    Warming Berry
    Flavored Liquid

    12 FL OZ (354 mL)

    DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    Drug Facts

    Active ingredient                                                           Purpose
    (in each 30 mL dose cup or 2 tablespoons)
    Diphenhydramine HCI 50 mg…………………………Nighttime sleep-aid

    Uses
    ■ reduces time to fall asleep if you have difficulty falling asleep
    ■ for 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 any other drugs that cause drowsiness such as
    antihistamines and nighttime cough, cold/flu products

    Ask a doctor before use if you have
    ■ heart disease
    ■ trouble urinating due to enlarged prostrate gland
    ■ glaucoma
    ■ a breathing problem such as asthma, emphysema or chronic
    bronchitis

    Ask a doctor or pharmacist before use if you are taking
    sedatives or tranquilizers or any other sleep aid

    When using this product
    ■ do not use more than directed
    ■ avoid alcoholic beverages and other drugs that cause drowsiness
    ■ drowsiness will occur
    ■ be careful when driving a motor vehicle or operating machinery
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if
    ■ sleeplessness persists continuously for more than 2 weeks.
    Insomnia may be a symptom of 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 right away. ►

    Drug Facts(continued)

    Directions
    ■ take only as recommended
    ■ Use dosage cup or tablespoon

            Age                                         Dose
    Adults & children 12           One Dose = 2 tablespoons (30 mL) at bed
    years & over                     time if needed or as directed by a doctor

    Other information
    ■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg
    ■ dosage cup provided
    ■ store at room temperature

    Inactive ingredients
    citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn
    syrup, poloxamer 407, propylene glycol, purified water, sodium
    benzoate, sodium citrate, sodium saccharin

    Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
    1-877-798-5944

    *This product is not manufactured or distributed by Procter
    & Gamble, owner of the registered trademark ZzzQuil™

    Manufactured by: AptaPharma Inc.,
    1533 Union Ave.,
    Pennsauken, NJ 08110

    AP-LR-10

    NigTimeSleepAid

    NigTimeSleepAid

    6 OZ

    6 oz label6 oz label

    4 OZ

    4 oz label4 oz label

    res

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID  NON-HABIT FORMING
    diphenhydramine hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-522
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-522-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    2NDC:76281-522-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    3NDC:76281-522-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-522)