Label: ALLERGY- diphenhydramine hydrochloride tablet

  • NDC Code(s): 41250-479-53, 41250-479-62, 41250-479-67, 41250-479-78
  • Packager: Meijer Distribution Inc
  • 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 February 1, 2019

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

  • Active ingredient (in each tablet)

    Diphenhydramine 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
    itchy nose or throat
    temporarily relieves these symptoms of the common cold:
    runny nose
    sneezing
  • Warnings

    Do not use

    to make a child sleepy
    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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    take every 4 to 6 hours, or as directed by a doctor
    do not take more than 6 doses in 24 hours

    adults and children 12 years and over

    1 to 2 tablets

    children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use

  • Other information

    each tablet contains: calcium 20 mg
    store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
    do not use if blister unit is broken or torn
  • Inactive ingredients

    carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Benadryl® active ingredient

    MULTI-SYMPTOM

    allergy tablets

    Diphenhydramine HCl 25 mg | Antihistamine

    RELIEF OF: Sneezing; Itchy, Watery Eyes; Runny Nose & Itchy Throat

    24 Tablets | actual size

    479-6e-allergy-tablets.jpg
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-479
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorPINK (dark) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L479;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-479-6224 in 1 CARTON09/06/1991
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41250-479-6748 in 1 CARTON03/12/1998
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41250-479-781 in 1 CARTON05/27/1993
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41250-479-5312 in 1 CARTON07/06/2018
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/06/1991
    Labeler - Meijer Distribution Inc (006959555)