Label: BETR REMEDIES ALLERGY RELIEF- diphenhydramine hydrochloride tablet

  • NDC Code(s): 80267-100-62, 80267-100-78
  • Packager: Live Betr LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 4, 2023

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  • 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
    •
    itching of the 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

    Betr remedies™

    allergy relief

    Diphenhydramine HCl 25 mg

    Antihistamine | 4-6 hour

    Relief Of Sneezing; Runny Nose; Itchy Watery Eyes; Itchy Throat Or Nose

    Actual Size

    Compare to Benadryl® active ingredient.

    …If you are comparing.

    24 TABLETS

    allergy relief-image
  • INGREDIENTS AND APPEARANCE
    BETR REMEDIES ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80267-100
    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 (120 .MU.M) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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:80267-100-6224 in 1 CARTON07/24/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:80267-100-781 in 1 CARTON10/04/2023
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/24/2023
    Labeler - Live Betr LLC (117423281)
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