Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 59970-082-24
  • Packager: Navarro Discount Pharmacies,LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCL 25mg

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  • Purpose

    Antihistamine

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  • 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
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  • Warnings

    Do not use with any other product containing diphenhydramine, even one used on skin

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  • Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
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  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

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  • When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

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

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  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours

    adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
    children 6 to under 12 years of age 25 mg (1 tablet)

    children under 6 years of age

    children under 4 years of age

    ask a doctor

    do not use

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  • Other information

    • each tablet contains:calcium 0.1mg
    • store at 59° to 77°F in a dry place
    • protect from light
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  • Inactive ingredients

    FD&C red no. 40, hypromellose 2910, hydroxypropyl cellulose, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, silicic acid anhydride, stearic acid, titanium dioxide

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  • Package label

    Allergy Reliefimage of Allergy Relief cartonimage description

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59970-082
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    HYPROMELLOSE 2910 (50 MPA.S)  
    HYDROXYPROPYL CELLULOSE  
    CELLULOSE, MICROCRYSTALLINE  
    ANHYDROUS LACTOSE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    SILICON DIOXIDE  
    STEARIC ACID  
    POLYETHYLENE GLYCOL 6000  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color pink Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code ZN75
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59970-082-24 2 in 1 BOX
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
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