Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule

  • NDC Code(s): 61010-4409-0, 61010-4409-1, 61010-4409-2
  • Packager: Safetec of America, 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 January 27, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    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 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

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    adults and children 12 years and over 1 to 2 capsules
    children 6 to under 12 years 1 capsule
    children under 6 years do not use
  • Other information

    • each capsule contains: calcium 20 mg
    • store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light
  • Inactive ingredients

    benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate

  • Questions or comments?

    Call toll free: 1-800-456-7077

  • Principal Display Panel - 25 mg Pouch Label

    Safetec
    of America, Inc.

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    Manufactured for Safetec of America, Inc.
    Buffalo NY 14215

    Allergy Relief

    Diphenhydramine HCl

    antihistamine 2 Capsules

    Principal Display Panel - 25 mg Pouch Label
  • Principal Display Panel – 50 Pouches Carton Label

    Safetec®
    of America, Inc.

    *Compare to the active ingredient in Benadryl®

    NDC 61010-4409-1

    Allergy Relief

    Diphenhydramine HCl 25 mg

    PUSH TO OPEN

    Dispense through opening

    Antihistamine

    • Itchy Watery Eyes
    • Sneezing
    • Runny Nose

    TAMPER EVIDENT UNIT DOSE POUCHES

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    50 Pouches 2 Capsules per pouchPrincipal Display Panel – 50 Pouches Carton Label
Graphic-Untitled

  • Principal Display Panel – 100 Pouches Carton Label

    Safetec®
    of America, Inc.

    *Compare to the active ingredient in Benadryl®

    NDC 61010-4409-2

    Allergy Relief

    Diphenhydramine HCl 25 mg – Antihistamine

    • Itchy Watery Eyes
    • Sneezing
    • Runny Nose

    PUSH TO OPEN

    Dispense through opening

    TAMPER EVIDENT UNIT DOSE POUCHES

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    100 Pouches 2 Capsules per pouch

    Principal Display Panel – 100 Pouches Carton Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4409
    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
    benzyl alcohol (UNII: LKG8494WBH)  
    butylparaben (UNII: 3QPI1U3FV8)  
    D&C red NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorpink (PINK) , white ( WHITE) Scoreno score
    ShapeOVAL (OVAL) Size14mm
    FlavorImprint Code AP;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4409-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
    2NDC:61010-4409-150 in 1 BOX12/30/2019
    2NDC:61010-4409-02 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61010-4409-2100 in 1 BOX12/30/2019
    3NDC:61010-4409-02 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2019
    Labeler - Safetec of America, Inc. (874965262)