Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    25 mg Tablets

    For Hospital Use Only

    Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine 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 nose
    • temporarily relieves these symptoms due to 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

    • Use as directed per healthcare professional.
    • 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 older1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use
  • Other information

    • each tablet contains: calcium 20 mg
    • store at 20-25°C (68-77°F).
    • Avoid high humidity. Protect from light
    • small tablet size, easy to swallow
  • 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?

    1-800-397-9228

    Gluten Free

  • How Supplied

    They are supplied as follows:
    NDC 68094-018-61
    Unit Dose Packages of 100 Tablets (10×10) per Carton

  • SPL UNCLASSIFIED SECTION

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

    LI1499
    Rev. 10/23

  • PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label

    Precision Dose™

    NDC 68094-018-61
    Unit Dose

    diphenhydrAMINE HCl
    25 mg Tablets
    100 Tablets
    (10x10)

    Each tablet contains:
    Diphenhydramine Hydrochloride  25 mg
    Calcium  20 mg

    Gluten Free

    USUAL DOSE: SEE ENCLOSED INSERT.

    Store at 20-25°C (68-77°F).
    Avoid high humidity. Protect from light.

    Keep out of reach of children.
    Hospital Use Only.

    LC1498
    R0

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-018(NDC:0113-0479)
    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)  
    anhydrous dibasic calcium phosphate (UNII: L11K75P92J)  
    Product Characteristics
    ColorPINK (dark) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L479;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-018-6110 in 1 CARTON07/15/2019
    1NDC:68094-018-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01207/15/2019
    Labeler - Precision Dose, Inc. (035886746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Precision Dose, Inc.035886746REPACK(68094-018)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!