Label: SOHMED ALLERGY- diphenhydramine hydrochloride 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 August 20, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

    Do not use 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.

    Overdose warning

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

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 times in 24 hours
    adults and children 12 years and over1 to 2 caplets
    children 6 to under 12 years1 caplet
    children under 6 yearsconsult a doctor
  • Other information

    • Store between 20°-25°C (68°-77°F).
      Avoid high humidity. Protect from light
    • See end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide, May contain polysorbate.

  • Question or comments?

    1 (856) 2863646

  • SPL UNCLASSIFIED SECTION

    Distributed by : Sohm, Inc.
    6920 Knott Ave., Suit A-C,
    Buena Park, CA 90621

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

    NDC XXXXXXXXXX

    SohMed™
    *Compare to the active ingredients in Benadryl® Allergy Ultratab®

    Antihistamine

    Allergy

    Diphenhydramine HCl 25 mg

    24 Caplets

    • Runny Nose • Itchy, Watery Eyes
    • Sneezing • Itchy throat

    Principal Display Panel - 24 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SOHMED ALLERGY 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50405-004
    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 RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Product Characteristics
    ColorREDScore2 pieces
    ShapeOVALSize11mm
    FlavorImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50405-004-241 in 1 CARTON
    124 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/25/2013
    Labeler - SOHM Inc. (009303848)
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