HEADACHE RELIEF TO GO- acetaminophen 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
Acetaminophen 650 mgPain reliever
Caffeine 50 mgPain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 powders in 24 hours which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product limit the 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

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Inactive ingredients

acesulfame potassium, citric acid, ethylcellulose, flavor, sodium chloride, sucralose, sucrose

Questions?

1-888-99-URGENT (1-888-998-7436) (Mon-Fri 9AM-5PM MDT)

Do not use if pouch
is torn or open

distributed by
UrgentRx®
Breakthrough Products, Inc.
Denver, CO 80202

PRINCIPAL DISPLAY PANEL - Pouch Label

New
Formula!

Now with
Acetaminophen

FAST POWDERS™
No Liquid Required
Pour Directly in Mouth

SEE OPENING INSTRUCTIONS ON BACK PANEL

HEADACHE

URGENTRx

RELIEF
TO-GO

ACETAMINOPHEN + CAFFEINE/PAIN RELEIVER + ADJUVANT

sweet orange

distributed by UrgentRx

1 powder pack

Principal Display Panel - Pouch Label
HEADACHE RELIEF TO GO 
acetaminophen and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51596-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) acetaminophen650 mg
caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E) caffeine50 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
citric acid monohydrate (UNII: 2968PHW8QP)  
ethylcelluloses (UNII: 7Z8S9VYZ4B)  
sodium chloride (UNII: 451W47IQ8X)  
sucralose (UNII: 96K6UQ3ZD4)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51596-010-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/15/2014
Labeler - Breakthrough Products Inc. (962008251)

Revised: 6/2014
Document Id: bf6a7b84-37ef-4a46-9c3f-cf15b87648b6
Set id: a5f925b6-2905-4264-ac53-c0a436328af0
Version: 1
Effective Time: 20140616
 
Breakthrough Products Inc.