FDA.reportPublic FDA data

First Aid Shot Therapy Pain Relief

Manufacturer
First Aid Beverages, Inc.
Effective date
2015-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:34

Label at a glance#

ProductFirst Aid Shot Therapy Pain Relief
Active ingredientCholine Salicylate, Caffeine
Label structure10 sections

Indications and uses

headache muscle pain toothache menstrual pain pain of colds minor pain of arthritis

Dosage and administration

Adults and children 12 years and over: swallow the contents of one bottle repeat every 3-4 hours while symptoms persist do not take more than 6 bottles in 24 hours Children under 12 years: Do not use

Storage and handling

keep from freezing avoid excessive heat (over 104°F or 40°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Choline salicylate 650 mg (NSAID)* Pain reliever
Caffeine 65 mgPain reliever aid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain of colds
  • minor pain of arthritis

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: contains salicylate

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 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 a longer time than directed

OTC - DO NOT USE SECTION

Do not use if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

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

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • 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 occasional rapid heartbeat

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs (seek medical help right away)
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • 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.

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:
    • swallow the contents of one bottle
    • repeat every 3-4 hours while symptoms persist
    • do not take more than 6 bottles in 24 hours
  • Children under 12 years: Do not use

Other information

STORAGE AND HANDLING SECTION

  • keep from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, natural and artificial flavors, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-877-958-8331 (Monday-Friday 9AM-5PM PST). You may also report serious side effects to this number.

SPL UNCLASSIFIED SECTION

Distributed by
First Aid Shot Therapy®
Burlingame, CA 94010

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

●
PAIN

FAST
– LIQUID –
RELIEF®

FIRST AID
SHOT THERAPY®

BERRY

FDA
COMPLIANT

choline salicylate & caffeine
pain reliever
(NSAID)/pain reliever aid

1.35 FL OZ (40mL)

PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1600925choline salicylate 650 MG / caffeine 65 MG in 40 mL Oral SolutionPSN1
1600925caffeine 1.63 MG/ML / choline salicylate 16.3 MG/ML Oral SolutionSCD1
1600925caffeine 65 MG / choline salicylate 650 MG per 40 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57815-081-012020-01-31C16284748780-19d75b9d0-0190-f424-e053-dadaa90a57ceFirst Aid Shot Therapy ® Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57815-081-01First Aid Shot Therapy Pain Relief40 mL in 1 BOTTLE, PLASTICLIQUID401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57815-081FIRST AID SHOT THERAPY PAIN RELIEF (CHOLINE SALICYLATE AND CAFFEINE) LIQUID [FIRST AID BEVERAGES, INC.]1Legacy NDC, 1 package rows20150201_97e061b3-4e2e-4fdf-ba07-c300a2337713.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CaffeineACTIVE INGREDIENT3G6A5W338E1
Choline SalicylateACTIVE INGREDIENTKD510K1IQW1
CaffeineACTIVE MOIETY3G6A5W338E1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSL1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD41
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57815-08157815-081-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Choline SalicylateKD510K1IQWACTIB
Caffeine3G6A5W338EACTIB
Anhydrous Citric AcidXF417D3PSLIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Citrate1Q73Q2JULRIACT
Sucralose96K6UQ3ZD4IACT
Water059QF0KO0RIACT

Source Document#

Source XML

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 2 · 118 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact 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 ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLFILM / BUCCAL9 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii candidate
61 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 ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / SUBCUTANEOUS101 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 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 ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 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 ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RECTAL904 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 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
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact 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
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 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
30e7cd1c-f8da-4812-bc86-9f73c70764bb97e061b3-4e2e-4fdf-ba07-c300a23377132015-01-21WarningsExact identifier
spl id: 30e7cd1c-f8da-4812-bc86-9f73c70764bb
spl set id: 97e061b3-4e2e-4fdf-ba07-c300a2337713

Reported adverse events (FAERS/openFDA)#

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