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Headache Relief To Go by Breakthrough Products Inc.

Dosage form: powder
Ingredients: acetaminophen 650mg, caffeine 50mg
Labeler: Breakthrough Products Inc.
NDC Code: 51596-010

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.

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:

  • headache
  • muscular aches

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
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
  • see instructions above for opening packet
  • place 1 powder on the tongue and swallow with or without water
  • repeat every 4-6 hours, wile symptoms persist
  • do not take more than 6 pouches in 24 hours
  • children under 12 years: ask a doctor

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

HEADACHE RELIEF TO GO 
acetaminophen and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51596-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen650 mg
caffeine (caffeine) caffeine50 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
citric acid monohydrate 
ethylcelluloses 
sodium chloride 
sucralose 
sucrose 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51596-010-011 POWDER 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: 06/2014
 
Breakthrough Products Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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