CRITICAL CARE 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.

----------

Critical Care Aspirin to Go

Drug Facts

Active ingredient (per powder)

Aspirin 325mg (NSAID)1


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Temporarily relieves:

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 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:

children under 12 years: ask a doctor

Inactive ingredients

acesulfame potassium, citric acid, flavor, glucose, sucralose

Questions?

1-888-998-7436 (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 - 325 mg Pouch Label

New!

Be prepared.
Discover the
life saving
benefits of
aspirin.

Ask your doctor.

NO
WATER
REQUIRED
POUR DIRECTLY IN MOUTH

SEE OPENING INSTRUCTIONS ON BACK PANEL

CRITICAL
CARE
325
mg

URGENT Rx®

ASPIRIN
TO-GO

ASPIRIN (NSAID) /
PAIN RELIEVER

lemon-lime

distributed by UrgentRx
1 POWDER PACK

PRINCIPAL DISPLAY PANEL - 325 mg Pouch Label
CRITICAL CARE ASPIRIN TO GO 
aspirin powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-006
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin 325 mg
Inactive Ingredients
Ingredient Name Strength
acesulfame potassium (UNII: 23OV73Q5G9)  
anhydrous citric acid (UNII: XF417D3PSL)  
dextrose (UNII: IY9XDZ35W2)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor LEMON (Lemon-Lime) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51596-006-05 5 in 1 BOX
1 1 in 1 POUCH; Type 0: Not a Combination Product
2 NDC:51596-006-12 12 in 1 BOX
2 1 in 1 POUCH; Type 0: Not a Combination Product
3 NDC:51596-006-24 24 in 1 BOX
3 1 in 1 POUCH; Type 0: Not a Combination Product
4 NDC:51596-006-01 1 in 1 POUCH; Type 0: Not a Combination Product
5 NDC:51596-006-10 10 in 1 BOX
5 1 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 10/01/2012
Labeler - Breakthrough Products Inc. (962008251)

Revised: 10/2014
Document Id: 3ad5094c-8ce5-4f05-af55-f0448f06cdfb
Set id: a2ab9dd8-9f3b-4658-9218-ad2a3f820ffe
Version: 4
Effective Time: 20141006
 
Breakthrough Products Inc.