Your browser does not support JavaScript! ALLERGY ATTACK RELIEF TO GO (DIPHENHYDRAMINE HYDROCHLORIDE) POWDER [BREAKTHROUGH PRODUCTS INC.]
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ALLERGY ATTACK RELIEF TO GO (diphenhydramine hydrochloride) powder
[Breakthrough Products Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts

Active ingredient (per powder)

Diphenhydramine HCl 25 mg

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 the 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 of age and over

  • see instructions above for opening packet
  • place 25 mg (1 powder) to 50 mg (2 powders) on the tongue and swallow with or without water
  • take every 4 to 6 hours
  • do not take more than 300 mg (12 powders) in 24 hours
  • children 6 to under 12 years of age
    • place 12.5 mg (this dose strength is not available in this package) to 25 mg (1 powder) on the tongue and swallow with or without water
    • take every 4 to 6 hours
    • do not take more than 150 mg (6 powders) in 24 hours
    • do not attempt to divide the powder in half
  • children under 6 years of age
    • do not use

Inactive ingredients

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

Questions?

1-888-99-URGENT (Mon-Fri 9AM-5PM MDT)

Do not use if pouch
is torn or open

distributed by
URGENT Rx®
Breakthrough Products, Inc.

Denver, CO 80202

PRINCIPAL DISPLAY PANEL - Pouch Label

New!

RIGHT
NOW
RELIEF

No Liquid Required
FAST POWDERS
Pour Directly In Mouth

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
ALLERGY ATTACK RELIEF TO GO 
diphenhydramine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51596-009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
ETHYLCELLULOSES 
HYDROXYPROPYL CELLULOSE (TYPE H) 
sucralose 
sucrose 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51596-009-055 in 1 BOX
1NDC:51596-009-011 in 1 POUCH
2NDC:51596-009-1212 in 1 BOX
21 in 1 POUCH
3NDC:51596-009-2424 in 1 BOX
31 in 1 POUCH
4NDC:51596-009-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2012
Labeler - Breakthrough Products Inc. (962008251)

Revised: 11/2013
 
Breakthrough Products Inc.

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