ACHE AND PAIN RELIEF TO GO- aspirin and caffeine powder

Ache and Pain Relief to Go by

Drug Labeling and Warnings

Ache and Pain 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (per powder)	Purpose
* nonsteroidal anti-inflammatory drug
Aspirin 650mg (NSAID)*	Pain reliever
Caffeine 60mg	Pain reliever aid

Uses

Temporarily relieves:

• muscle pain
• minor arthritis pain
• headache
• pain 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 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)

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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 - 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

INGREDIENTS AND APPEARANCE

ACHE AND PAIN RELIEF TO GO 
aspirin and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51596-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)	aspirin	650 mg
caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)	caffeine	60 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: 51596-008-05	5 in 1 BOX
1	NDC: 51596-008-01	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 51596-008-12	12 in 1 BOX
2	NDC: 51596-008-01	1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 51596-008-24	24 in 1 BOX
3	NDC: 51596-008-01	1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 51596-008-01	1 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 51596-008-10	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)