Label: ALLERGY ATTACK RELIEF TO GO- diphenhydramine hydrochloride powder

  • 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 October 9, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per powder)

    Diphenhydramine HCl 25mg

  • Purpose

    Antihistamine

  • Uses

    Temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose and throat

    Temporarily relieves these symptoms due to common cold:

    • runny nose
    • sneezing
  • Warnings

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

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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. Do not use to make a child sleepy.

  • Directions

    adults and children 12 years and over:

    • see instructions in red box for opening packet
    • place 25mg (1 powder) to 50mg (2 powders) on the tongue and swallow with or without water
    • take every 4 to 6 hours
    • do not take more than 300mg (12 powders) in 24 hours

    children 6 to under 12 years of age:

    • place 12.5mg (this dose strength is not available in this package) to 25mg (1 powder) on the tongue and swallow with or without water
    • take every 4 to 6 hours
    • do not take more than 150mg (6 powders) in 24 hours
    • do not attempt to divide a powder in half

    children under 6 years of age: do not use

  • Inactive ingredients

    citric acid, ethylcellulose, flavor, glucose, hydroxypropyl cellulose, starch, sucralose, sucrose

  • Questions?

    1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open

    distributed by
    URGENT Rx    ®
    Breakthrough Products, Inc.
    Denver, CO 80202

  • PRINCIPAL DISPLAY PANEL - 1 Powder Packet

    New!

    NO
    WATER
    REQUIRED
    POUR DIRECTLY IN MOUTH

    URGENT Rx®
    FAST
    POWDERS     ™

    SEE OPENING INSTRUCTIONS ON BACK PANEL

    ALLERGY
    ATTACK

    URGENT Rx®

    RELIEF
    TO-GO    ™

    DIPHENHYDRAMINE HCl /
    ANTIHISTAMINE

    raspberry

    distributed by UrgentRx
    1 POWDER PACK

    Principal Display Panel - 1 Powder Packet
  • INGREDIENTS AND APPEARANCE
    ALLERGY ATTACK RELIEF TO GO 
    diphenhydramine hydrochloride powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51596-009
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    dextrose (UNII: IY9XDZ35W2)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51596-009-1010 in 1 BOX
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:51596-009-055 in 1 BOX
    2NDC:51596-009-011 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:51596-009-1212 in 1 BOX
    31 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:51596-009-2424 in 1 BOX
    41 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:51596-009-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/01/2012
    Labeler - Breakthrough Products Inc. (962008251)
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