FDA Label for Ache And Pain Relief To Go

View Indications, Usage & Precautions

Ache And Pain Relief To Go Product Label

The following document was submitted to the FDA by the labeler of this product Breakthrough Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Do not use if pouch
is torn or open

distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202


Otc - Purpose



Active ingredients (per powder)Purpose
Aspirin 650mg (NSAID)

nonsteroidal anti-inflammatory drug

Pain reliever
Caffeine 60mgPain reliever aid

Uses



Temporarily relieves:

  • muscle pain
  • minor arthritis pain
  • headache
  • pain of colds

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

Otc - Do Not Use



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

Otc - Ask Doctor/Pharmacist



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

  • gout
  • diabetes
  • arthritis

Otc - When Using



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

Otc - Pregnancy Or Breast Feeding



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.


Otc - Keep Out Of Reach Of Children



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:

  • see instructions in red box for opening packet
  • 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, glucose, sucralose


Questions?



1-888-998-7436 (Mon-Fri 9AM-5PM MDT)


Principal Display Panel - 1 Powder Packet



New!

NO
WATER
REQUIRED
POUR DIRECTLY IN MOUTH

URGENT Rx®
FAST
POWDERS

◀ SEE OPENING INSTRUCTIONS ON BACK PANEL ▶

ACHE &
PAIN

URGENT Rx®
RELIEF
TO-GO

ASPIRIN (NSAID) + CAFFEINE /
PAIN RELIEVER + ADJUVANT

lemon-lime

distributed by UrgentRx
1 POWDER PACK


* Please review the disclaimer below.