FDA.reportPublic FDA data

TOPCARE PAIN RELIEVER SIMPLE RELIEF

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2016-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:52

Label at a glance#

ProductTOPCARE PAIN RELIEVER SIMPLE RELIEF
Active ingredientCAFFEINE, CHOLINE SALICYLATE
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: ○ headache ○ minor arthritis pain ○ muscle aches ○ menstrual cramps ○ backache temporarily reduces fever

Dosage and administration

adults and children 12 years of age and over: take 30 mL every 6 hours, while symptoms persist do not exceed 4 doses in 24 hours unless directed by a doctor children under 12 years of age: ask a doctor use enclosed dose cup

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TopCare Pain Reliever Simple Relief ™ 

(choline salicylate & caffeine), solution

Topco Associates LLC

--

Topco Associates LLC. Pain Reliever Drug Facts

Drug Facts

Active Ingredients per 30mL

OTC - ACTIVE INGREDIENT SECTION

Caffeine 65 mg

Choline Salicylate (NSAID)* 870 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever Aid

Pain Reliever / Fever Reducer (NSAID)

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    ○ headache
    ○ minor arthritis pain
    ○ muscle aches
    ○ menstrual cramps
    ○ backache
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox 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

Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

  • hives
  • skin reddening
  • rash
  • facial swelling
  • shock
  • asthma (wheezing)

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 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

Do not use

OTC - DO NOT USE SECTION

  • if you ever had an allergic reaction to salicylates (including 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking a prescription drug for anticoagulation (thinning of the blood), diabetes, gout, or arthritis.

When using this product

OTC - WHEN USING SECTION

  • limit the use of caffeine containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat
  •  the recommended dose of this product contains about as much caffeine as a cup of coffee

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur
  • symptoms do not improve
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding, 

SPL UNCLASSIFIED SECTION

ask a health professional before use.  It is especially important not to use salicylates (NSAIDs) 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take 30 mL every 6 hours, while symptoms persist
  • do not exceed 4 doses in 24 hours unless directed by a doctor
  • children under 12 years of age: ask a doctor
  • use enclosed dose cup

Other Information

OTHER SAFETY INFORMATION

  • each 30mL contains: Sodium 19 mg
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • store at 68° to 86°F (20° to 30°C)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-518-34
Pain
Simple Relief
8 OZ FL (237mL)

PRINCIPAL DISPLAY PANEL NDC 36800-518-34 Pain Simple Relief 8 OZ FL (237mL)PRINCIPAL DISPLAY PANEL NDC 36800-518-34 Pain Simple Relief 8 OZ FL (237mL)

PRINCIPAL DISPLAY PANEL NDC 36800-518-34 Pain Simple Relief 8 OZ FL (237mL)PRINCIPAL DISPLAY PANEL NDC 36800-518-34 Pain Simple Relief 8 OZ FL (237mL)

PRINCIPAL DISPLAY PANEL NDC 36800-518-34 Pain Simple Relief 8 OZ FL (237mL)PRINCIPAL DISPLAY PANEL NDC 36800-518-34 Pain Simple Relief 8 OZ FL (237mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1994320caffeine 65 MG / choline salicylate 870 MG in 30 mL Oral SolutionPSN1
1994320caffeine 2.17 MG/ML / choline salicylate 29 MG/ML Oral SolutionSCD1
1994320caffeine 65 MG / choline salicylate 870 MG per 30 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
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
36800-518-342020-01-31C16284748780-19d75b9d0-9bbc-f424-e053-dadaa90a57ceTOPCARE PAIN RELIEVER SIMPLE RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-518-34TOPCARE PAIN RELIEVER SIMPLE RELIEF237 mL in 1 BOTTLESOLUTION2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-518TOPCARE PAIN RELIEVER SIMPLE RELIEF (CAFFEINE, CHOLINE SALICYLATE) SOLUTION [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20171230_fee15739-13ef-4ff3-b989-680c732af024.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-51836800-518-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
CHOLINE SALICYLATEKD510K1IQWACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

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
7434d73f-807b-4fe2-9796-db2ec9a7d4acfee15739-13ef-4ff3-b989-680c732af0242016-06-28WarningsExact identifier
spl id: 7434d73f-807b-4fe2-9796-db2ec9a7d4ac
spl set id: fee15739-13ef-4ff3-b989-680c732af024

Reported adverse events (FAERS/openFDA)#

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