Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet 

  • NDC Code(s): 11822-0329-2, 11822-0329-3, 11822-0329-4, 11822-0329-6, view more
    11822-0329-7, 11822-0329-8
  • Packager: Rite Aid
  • 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 08/13

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

    Close
  • Purpose

    Antihistamine

    Close
  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose

    • itchy, watery eyes

    • sneezing

    • itching of the nose or throat

    • temporarily relieves these symptoms due to the common cold:

    • runny nose

    • sneezing

    Close
  • Warnings

    Do not use

    • to make a child sleepy

    • ith any other product containing diphenhydramine, even one used on skin

    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

    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

    • 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.

    Close
  • 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

    1 to 2 tablets 
     children 6 to under 12 years of age  1 tablet   
     children under 6 years of age  do not use this product in children under 6 years of age
    Close
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)

    • protect from moisture

    • see end flap for expiration date and lot number

    Close
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

    Close
  • Principal Display Panel

    RITE AID®
    PHARMACY

    *Compare to the active ingredient in Benadryl® Allergy Ultratab®

    allergy relief
    diphenhydramine HCl 25 mg
    antihistamine

    48 MINITABS
    25 mg EACH
    SMALL TABLET SIZE

    relief of:
    sneezing
    itchy, watery eyes
    runny nose
    itchy throat

    easy to swallow

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
    50844        REV0512B32912

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE, CAMP HILL, PA 17011

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Rite Aid 44-329

    Rite Aid 44-329

    Close
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0329
    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
    CELLULOSE, MICROCRYSTALLINE  
    D&C RED NO. 27  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    SILICON DIOXIDE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;329
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0329-7 1 in 1 CARTON
    1 36 in 1 BLISTER PACK
    2 NDC:11822-0329-8 1 in 1 CARTON
    2 24 in 1 BLISTER PACK
    3 NDC:11822-0329-4 1 in 1 CARTON
    3 48 in 1 BLISTER PACK
    4 NDC:11822-0329-6 1 in 1 CARTON
    4 200 in 1 BOTTLE, PLASTIC
    5 NDC:11822-0329-2 1 in 1 CARTON
    5 100 in 1 BOTTLE, PLASTIC
    6 NDC:11822-0329-3 10 in 1 VIAL, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/02/1990
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0329)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0329)
    Close