Label: ONLY FOR ALLERGY- 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 November 18, 2020

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  • Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25mg

  • Purpose

    Antihistamine

  • Uses:

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
       • runny nose
       • sneezing
       • itchy, watery eyes
       • itching of the nose or throat

    • temporarily relieves these symptoms due to the common cold:
       • runny nose
       • sneezing

  • Warnings:

    Do not use
    • to make a child sleepy
    • 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
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children.

    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.

  • Directions:

    • take every 4 to 6 hours, or as directed by doctor
    • do not take more than 6 doses in 24 hours

     adults and children 12 years and over• take 1 to 2 caplets 
     children 6 to under 12 years• take 1 caplet
     children under 6 years• do not use

  • Other Information:

    • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
    • avoid excessive heat and light.
    • store in dry place.

  • Inactive Ingredients:

    croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    1-833-665-9444.
    (Mon-Fri 9am - 5pm)

  • SPL UNCLASSIFIED SECTION

    ANTIHISTAMINE NIGHTTIME SLEEP-AID

    TAMPER EVIDENT Do not use if imprinted safety seal under cap is broken or missing

    Distributed By: O4 GLOBAL TRADING USA, LLC.
    12222 Merit Drive, Suite 1900
    Dallas, TX 75251-3209

    www.onlyfor.com

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

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ONLY FOR ALLERGY 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-148
    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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (CAPLET) Size11mm
    FlavorImprint Code DP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-148-951 in 1 CARTON11/15/2020
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33811/15/2020
    Labeler - O4 Global Trading Usa, Llc (081226861)
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