Label: NIGHTTIME SLEEP AID- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 41163-367-06, 41163-367-08, 41163-367-12
  • Packager: SUPERVALU INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 10, 2017

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

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Use

    for relief of occasional sleeplessness

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  • Warnings

    Do not use

    • in 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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • drowsiness will occur
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    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.

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  • Directions

    • do not take more than directed
    • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use 
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  • Other information

    • each caplet contains: calcium 30 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

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  • Questions or comments?

    1-877-932-7948

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  • Principal Display Panel

    compare to
    Simply Sleep®

    active ingredient*
    NDC 41163-367-06

    EQUALINE®

    nighttime
    sleep aid
    diphenhydramine HCl 25 mg (nighttime sleep aid)

    for a restful night's sleep
    • safe, non-habit forming

    DOES NOT CONTAIN PAIN RELIEVER

    actual size

    200 mini caplets

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
    50844        REV0516D36706

    DISTRIBUTED BY SUPERVALU INC.
    EDEN PRAIRIE, MN 55344 USA

    100% Quality
    GUARANTEED

    Like it or let us make it right.
    That's our quality promise.
    877-932-7948
    supervaluprivatebrands.com

    Equaline 44-367

    Equaline 44-367


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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-367
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code 44;367
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-367-08 2 in 1 CARTON 06/10/2000
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:41163-367-06 1 in 1 CARTON 06/10/2000
    2 200 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:41163-367-12 1 in 1 CARTON 06/10/2000
    3 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 06/10/2000
    Labeler - SUPERVALU INC. (006961411)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(41163-367)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(41163-367)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(41163-367)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(41163-367)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(41163-367)
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