Label: CONRX ALLERGY- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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 February 11, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Diphenydramine HCl 25 mg

  • 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 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
    • excitabiity 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 over 1 to 2 caplets

    children 6 to under 12 years 1 caplet,

    children under 6 years consult a doctor

  • Other information

    • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light
    • do not use if pouch is torn or open
    • see side panel for lot number and expiration date
  • Inactive ingredients

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

  • Questions or comments?

    1-800-570-8650

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Box

    Compare to the Active Ingredients in

    Benadryl®*

    ConRx™ Allergy

    ■ Watery Eyes ■ Sneezing ■ Runny Nose

    Diphenhydramine Hci | Antihistamine

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    Benadryl®*

    50 Pouches of 2 Caplets Each

    Principal Display Panel - 50 Pouch Box
  • INGREDIENTS AND APPEARANCE
    CONRX ALLERGY 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-230
    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:68737-230-1450 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/15/2013
    Labeler - Eagle Distributors,Inc. (929837425)
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