Label: ALLERGY ATTACK RELIEF TO GO- diphenhydramine hydrochloride powder

  • NDC Code(s): 51596-009-01, 51596-009-05, 51596-009-10, 51596-009-12, view more
    51596-009-24
  • Packager: Breakthrough Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (per powder)

    Diphenhydramine HCl 25mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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.

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  • 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

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  • Inactive ingredients

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

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  • Questions?

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

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  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open

    distributed by
    URGENT Rx
    ®
    Breakthrough Products, Inc.

    Denver, CO 80202

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  • 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
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  • INGREDIENTS AND APPEARANCE
    ALLERGY ATTACK RELIEF TO GO 
    diphenhydramine hydrochloride powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51596-009
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    ETHYLCELLULOSES  
    dextrose  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    sucralose  
    sucrose  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51596-009-10 10 in 1 BOX
    1 1 in 1 PACKET; Combination Product Type = C112160
    2 NDC:51596-009-05 5 in 1 BOX
    2 NDC:51596-009-01 1 in 1 POUCH; Combination Product Type = C112160
    3 NDC:51596-009-12 12 in 1 BOX
    3 1 in 1 POUCH; Combination Product Type = C112160
    4 NDC:51596-009-24 24 in 1 BOX
    4 1 in 1 POUCH; Combination Product Type = C112160
    5 NDC:51596-009-01 1 in 1 POUCH; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/01/2012
    Labeler - Breakthrough Products Inc. (962008251)
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