HEADACHE RELIEF TO GO- aspirin and caffeine powder

Headache Relief to Go by

Drug Labeling and Warnings

Headache Relief to Go by is a Otc medication manufactured, distributed, or labeled by Breakthrough Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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

• see instructions above for opening packet
• place 1-2 powders on the tongue and swallow with or without water
• repeat every 4-6 hours, while symptoms persist
• do not take more than 8 powders in 24 hours
• children under 12 years: Ask a doctor

Inactive ingredients

acesulfame potassium, citric acid, flavor, glucose, sucralose

Questions?

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

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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

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF TO GO 
aspirin and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51596-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)	aspirin	325 mg
caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)	caffeine	30 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: 51596-007-05	5 in 1 BOX
1	NDC: 51596-007-01	1 in 1 POUCH
2	NDC: 51596-007-12	12 in 1 BOX
2	NDC: 51596-007-01	1 in 1 POUCH
3	NDC: 51596-007-24	24 in 1 BOX
3	NDC: 51596-007-01	1 in 1 POUCH
4	NDC: 51596-007-01	1 in 1 POUCH

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)