Label: DIPHENHYDRAMINE - diphenhydramine hydrochloride tablet, coated

  • NDC Code(s): 57344-090-01, 57344-090-02, 57344-090-03, 57344-090-05, view more
    57344-090-06
  • Packager: AAA Pharmaceutical, Inc.
  • 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 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • 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
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
    Close
  • Warnings

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

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    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
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery

    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 exceed 6 doses in 24 hours
    *
    12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
    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 12.5 mg* to 25 mg (1 tablet)
    children under 6 years of age ask a doctor
    Close
  • Other information

    • each tablet contains: calcium 45 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • retain carton for complete product information
    Close
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

    Close
  • PRINCIPAL DISPLAY PANEL - 48 Tablet Carton

    RESTORE u

    NDC 57344-090-02

    COMPARE TO THE ACTIVE
    INGREDIENT IN BENADRYL®
    ALLERGY ULTRATABS®

    Allergy Relief

    Antihistamine
    Diphenhydramine HCI

    Easy To
    Swallow

    Relieves: • Sneezing • Runny Nose
    • Itchy, Watery Eyes • Itchy Throat

    48 TABLETS

    PRINCIPAL DISPLAY PANEL - 48 Tablet Carton
    Close
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE  
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-090
    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
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 27  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color PINK Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code 25;052
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-090-01 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:57344-090-02 4 in 1 CARTON
    2 12 in 1 BLISTER PACK
    3 NDC:57344-090-03 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    4 NDC:57344-090-05 400 in 1 BOTTLE, PLASTIC
    5 NDC:57344-090-06 2 in 1 CARTON
    5 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/22/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Close