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Name:Aspirin To Go
Manufacturer:Breakthrough Products Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Urgent•Rx® Aspirin to GO

ASPIRIN TO GO - aspirin powder 
Breakthrough Products Inc.

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.

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Urgent•Rx®
Aspirin
to GO

Drug Facts

Active Ingredient (per powder)

Aspirin 325 mg (NSAID)1


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves
  • headache
  • toothache
  • pain and fever of colds
  • muscle pain
  • menstrual pain
  • minor pain of arthritis

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer than directed

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • an allergic reaction occurs (seek medical help right away)
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever lasts more than 3 days
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over

  • place 1 powder on the tongue and swallow with or without water
  • repeat every 4-6 hours, while symptoms persist
  • do not take more than 4 powders in 24 hours
  • children under 12 years: Ask a doctor

Inactive ingredients

acesulfame potassium, citric acid, flavor, isomalt, sucralose, water

Questions?

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

www.urgentRx.com

Do not use if pouch is torn or open

distributed by

Urgent•Rx®
Aspirin to Go

Breakthrough Products, Inc.
Denver, CO 80202

DETACH TOP & STORE IN WALLET

PRINCIPAL DISPLAY PANEL - Pouch Label

NEW!

distibuted by

Urgent•Rx®

TEAR HERE
TO OPEN

Aspirin
to GO

Pain Reliever (NSAID) /
Fever Reducer

ONE DOSE
NO LIQUID REQUIRED

325mg Dose
Fits in Wallet
Fast-Acting Powder

lemon lime
1 POWDER

Principal Display Panel - Pouch Label

ASPIRIN TO GO 
aspirin powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-001
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (aspirin) aspirin 325 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
CITRIC ACID MONOHYDRATE  
SUCRALOSE  
WATER  
ISOMALT  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor LEMON (LEMON LIME) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51596-001-01 1 POWDER ( POUCH) in 1 POUCH None
2 NDC:51596-001-24 24 POUCH ( POUCH) in 1 BOX contains a POUCH
2 1 POWDER ( POUCH) in 1 POUCH This package is contained within the BOX (51596-001-24)
3 NDC:51596-001-36 36 POUCH ( POUCH) in 1 BOX contains a POUCH
3 1 POWDER ( POUCH) in 1 POUCH This package is contained within the BOX (51596-001-36)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 12/15/2010

Labeler - Breakthrough Products Inc. (962008251)

Revised: 10/2010 Breakthrough Products Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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