HEADACHE 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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Headache Relief to Go

Drug Facts

Active Ingredients (per powder)Purpose
*
nonsteroidal anti-inflammatory drug
Aspirin 325 mg (NSAID)*Pain reliever
Caffeine 30 mgPain reliever aid

Uses

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

Inactive ingredients

acesulfame potassium, citric acid, flavor, glucose, sucralose

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

HEAD
ACHE

URGENT Rx®

RELIEF
TO-GO

ASPIRIN (NSAID) + CAFFEINE / PAIN RELIEVER + ADJUVANT

lemon-lime

distributed by UrgentRx
1 POWDER PACK

Principal Display Panel - Pouch Label
HEADACHE RELIEF TO GO 
aspirin and caffeine powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51596-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (aspirin) aspirin325 mg
caffeine (caffeine) caffeine30 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
anhydrous citric acid 
dextrose 
sucralose 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorLEMON (Lemon-Lime) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51596-007-055 in 1 BOX
1NDC:51596-007-011 in 1 POUCH
2NDC:51596-007-1212 in 1 BOX
2NDC:51596-007-011 in 1 POUCH
3NDC:51596-007-2424 in 1 BOX
3NDC:51596-007-011 in 1 POUCH
4NDC:51596-007-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/01/2012
Labeler - Breakthrough Products Inc. (962008251)

Revised: 11/2013
Document Id: 54d1f19d-5b36-4fec-84cf-25651a1a4f2c
Set id: 6ad5e8b7-b796-4c67-8d1e-01fd96ec4512
Version: 3
Effective Time: 20131105
 
Breakthrough Products Inc.