Label: ONLY FOR SLEEP- diphenhydramine hcl tablet

  • 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 April 25, 2019

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  • DRUG FACTS

  • Active ingredient (in each caplet)

    Diphenhydramine HCL 25mg

  • Purpose

    Nighttime sleep-aid

  • Uses:

    for relief of occasional sleeplessness

  • 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
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor before use if you
    are taking sedatives or tranquilizers

    When using this product

    • avoid alcoholic drinks
    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery

    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

    Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    • take with a full glass of water
    • do not take more than directed
       adults and children 12 years of age and over 2 caplets at bedtime if needed, or as directed by a doctor
       children under 12 years of age do not use

  • Other Information:

    • Store at room temperature between 20-25°C (68-77°F)
    • Avoid high humidity • Protect from light
  • Inactive Ingredients:

    Croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.

  • Questions Or Comments ?

    1-833-665-9444.

  • SPL UNCLASSIFIED SECTION

    NDC: 73006-111-41

    NIGHTTIME SLEEP-AID

    Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

    www.onlyfor.com

    Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

    Tear along perforation push product through foil

  • Packaging

    OnlyFor

  • INGREDIENTS AND APPEARANCE
    ONLY FOR  SLEEP
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-111
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (CAPLET) Size12mm
    FlavorImprint Code S1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-111-411 in 1 CARTON03/29/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33803/29/2019
    Labeler - O4 Global Trading Usa, Llc (081226861)
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