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Name:Ache And Pain Relief To Go
Manufacturer:Breakthrough Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Urgent•Rx® Ache & Pain Relief to GO

ACHE AND PAIN RELIEF TO GO - aspirin and caffeine 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®
Ache & Pain
Relief to GO

Drug Facts

Active Ingredient (per powder) Purpose
*
nonsteroidal anti-inflammatory drug
Aspirin 425 mg (NSAID)* Pain reliever/fever reducer
Caffeine 32.5 mg Pain reliever aid

Uses

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

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

When using this product limit use of caffeine containing drugs, foods, or drinks, because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat

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®
Ache & Pain Relief 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

Ache & Pain
Relief to GO

Aspirin (NSAID) + Caffeine
Pain Reliever + Adjuvant

ONE DOSE
NO LIQUID REQUIRED

Added Pain
Relief Booster
Fits in Wallet
Fast-Acting Powder

lemon lime
1 POWDER

Principal Display Panel - Pouch Label

ACHE AND PAIN RELIEF TO GO 
aspirin and caffeine powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-003
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (aspirin) aspirin 425 mg
caffeine (caffeine) caffeine 32.5 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:51596-003-01 1 POWDER ( POUCH) in 1 POUCH None
2 NDC:51596-003-24 24 POUCH ( POUCH) in 1 BOX contains a POUCH
2 1 POWDER ( POUCH) in 1 POUCH This package is contained within the BOX (51596-003-24)
3 NDC:51596-003-36 36 POUCH ( POUCH) in 1 BOX contains a POUCH
3 1 POWDER ( POUCH) in 1 POUCH This package is contained within the BOX (51596-003-36)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/15/2010

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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