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ALLERGY ATTACK RELIEF TO GO (diphenhydramine hydrochloride) powder
[Breakthrough Products Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2da1341d-5c2d-47ef-8498-f58fbb4f6300

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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, hydroxylpropyl cellulose, starch, sucralose, sucrose

Questions?

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

www.urgent Rx.com

Do not use if pouch
is torn or open

Allergy Attack Relief to Go

distributed by
UrgentRx®
Breakthrough Products, Inc.
Denver, CO 80202

PRINCIPAL DISPLAY PANEL - Pouch Label

New!

ridiculously
fast relief™

FAST POWDERS™
No Liquid Required
Pour Directly in Mouth

SEE OPENING INSTRUCTIONS ON BACK PANEL

ALLERGY ATTACK

URGENTRx

RELIEF TO-GO™

DIPHENHYDRAMINE HCl/ANTIHISTAMINE

raspberry

distributed by UrgentRx

1 POWDER PACK

ALLERGY ATTACK RELIEF TO GO
diphenhydramine hydrochloride powder

Product Information
Product Type	HUMAN OTC DRUG	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
citric acid monohydrate
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
sucralose
sucrose

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:51596-009-05	5 in 1 BOX
1	NDC:51596-009-01	1 in 1 POUCH
2	NDC:51596-009-12	12 in 1 BOX
2		1 in 1 POUCH
3	NDC:51596-009-24	24 in 1 BOX
3		1 in 1 POUCH
4	NDC:51596-009-01	1 in 1 POUCH

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)

Revised: 09/2012

Document Id: 258ee41a-c8fe-42bf-b8ca-d9bb82319727

Set id: 2da1341d-5c2d-47ef-8498-f58fbb4f6300

Version: 1

Effective Time: 20120919

Breakthrough Products Inc.

Daily Med

Current Medication Information

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