FDA.reportPublic FDA data

Headache Relief to Go

Manufacturer
Breakthrough Products Inc.
Effective date
2013-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:37:23

Label at a glance#

ProductHeadache Relief to Go
Active ingredientaspirin, caffeine
Label structure9 sections

Indications and uses

temporarily relieves muscle pain minor arthritis pain headache pain and fever of colds

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (per powder)Purpose
Aspirin 325 mg (NSAID)* Pain reliever
Caffeine 30 mgPain reliever aid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves
  • muscle pain
  • minor arthritis pain
  • headache
  • pain and fever of colds

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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 SECTION

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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 SECTION

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

  • gout
  • diabetes
  • arthritis

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • 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 SECTION

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 SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid, flavor, glucose, sucralose

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Do not use if pouch
is torn or open

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

PRINCIPAL DISPLAY PANEL - Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel - Pouch Label
Principal Display Panel - Pouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1312713aspirin 325 MG / caffeine 30 MG Oral PowderPSN3
1312713aspirin 325 MG / caffeine 30 MG Oral PowderSCD3
1312713ASA 325 MG / Caffeine 30 MG Oral PowderSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51596-007-012019-11-27C16284748780-19855e2a2-4bd8-60a7-e053-dbdaa90a05bdHeadache Relief to Go ™
51596-007-052019-11-27C16284748780-19855e2a2-4bd8-60a7-e053-dbdaa90a05bdHeadache Relief to Go ™
51596-007-122019-11-27C16284748780-19855e2a2-4bd8-60a7-e053-dbdaa90a05bdHeadache Relief to Go ™
51596-007-242019-11-27C16284748780-19855e2a2-4bd8-60a7-e053-dbdaa90a05bdHeadache Relief to Go ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51596-007-01Headache Relief to Go1 in 1 POUCHPOWDER13
51596-007-05Headache Relief to Go5 in 1 BOXPOWDER53
51596-007-12Headache Relief to Go12 in 1 BOXPOWDER123
51596-007-24Headache Relief to Go24 in 1 BOXPOWDER243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51596-007HEADACHE RELIEF TO GO (ASPIRIN AND CAFFEINE) POWDER [BREAKTHROUGH PRODUCTS INC.]3Legacy NDC, 4 package rows20131108_6ad5e8b7-b796-4c67-8d1e-01fd96ec4512.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76E3
caffeineACTIVE INGREDIENT3G6A5W338E3
aspirinACTIVE MOIETYR16CO5Y76E3
caffeineACTIVE MOIETY3G6A5W338E3
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G93
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL3
dextroseINACTIVE INGREDIENTIY9XDZ35W23
sucraloseINACTIVE INGREDIENT96K6UQ3ZD43

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51596-00751596-007-01, 51596-007-05, 51596-007-12, 51596-007-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
aspirinR16CO5Y76EACTIB
caffeine3G6A5W338EACTIB
acesulfame potassium23OV73Q5G9IACT
anhydrous citric acidXF417D3PSLIACT
dextroseIY9XDZ35W2IACT
sucralose96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 121 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii candidate
17 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / RESPIRATORY (INHALATION)5 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii candidate
61 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2POWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii candidate
61 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
21 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii candidate
17 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2LOZENGE / BUCCALNAExact identifier — unii candidate
21 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2TABLET / ORAL183.66 mgExact identifier — unii candidate
21 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2SOLUTION / INTRAVENOUS5.05 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii candidate
17 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
dextroseDEXTROSEIY9XDZ35W2SOLUTION / ORAL2489 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
acesulfame potassiumACESULFAME POTASSIUM23OV73Q5G9FILM / SUBLINGUAL5 mgExact identifier — unii candidate
17 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii candidate
61 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
61 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
54d1f19d-5b36-4fec-84cf-25651a1a4f2c6ad5e8b7-b796-4c67-8d1e-01fd96ec45122013-11-05WarningsExact identifier
spl id: 54d1f19d-5b36-4fec-84cf-25651a1a4f2c
spl set id: 6ad5e8b7-b796-4c67-8d1e-01fd96ec4512

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.