Aramark Pain-Free Extra Strength

Manufacturer
Western First Aid Safety DBA Aramark | ULTRA SEAL CORPORATION
Effective date
2021-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:42

Label at a glance#

ProductAramark Pain-Free Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts


Extra Strength Pain Reliever M560L
Active Ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin (NSAID) 250 mg
Caffeine 65 mg

OTC - PURPOSE SECTION

Acetaminophen ....Pain Reliever/Fever Reducer
Aspirin (NSAID) ....Pain Reliever/Fever Reducer
Caffeine ...............Adjuvent

INDICATIONS & USAGE SECTION

Uses:
Temporarily Relieves minor aches and pains
associated with: • backach • headaches
• colds • toothache • minor arthritis pain
• muscular aches • menstrual cramps

WARNINGS SECTION

Warnings:
• Reye’s Syndrome: Children and teenagers should not
  use this medicine for chicken pox or flu symptoms
  before a doctor is consulted about Reye’s Syndrome,
  a rare but serious illness reported to be associated
  with aspirin.
• Allergy Alert - Do not use:
   • if you are allergic to aspirin or any other salicylate
   • if you have ever had an allergic reaction to any
  other pain reliever/fever reducer
• Liver Warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
   • more than 8 tablets in 24 hours
   • with other drugs containing acetaminophen
     (Prescription or nonprescription)
   • Ask a doctor or pharmacist before using with
     other drugs if you are not sure.
   • 3 or more alcoholic drinks every day while
      using this product.
• Stomach Bleeding Warning: This product contains
  nonsteroidal anti-inflammatory drugs (NSAIDs),
  which may cause 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 an NSAID (aspirin,
      ibuprofen, naproxen, or others)
   • take more or for a longer time than directed

OTC - DO NOT USE SECTION

• Do not use:

   • with any other pain reliever/fever reducer
   • for pain for more than 10 days or for fever for
     more than 3 days unless directed by a doctor
   • if you have ever had an allergic reaction to
     any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

Ask a doctor before using if you have:
• upset stomach or stomach pain • gastric ulcers
• bleeding problems • asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
taking a prescription drug for:
• anticoagulation (thinning of blood)
• gout
• diabetes
• arthritis

OTC - WHEN USING SECTION

When using this product do not exceed the
recommended dose.

OTC - STOP USE SECTION

Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding baby, ask a health
professional before use. IT IS ESPECIALLY
IMPORTANT NOT TO USE ASPIRIN DURING THE
LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFICALLY 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. Prompt medical attention is critical for
adults as well as for children even if you do not
notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

 Directions:
  • Adults and
    children 12 years
    of age and older:
2 tablets as
needed for pain every
6 hours. Do not exceed
8 tablets in 24 hours or
as directed by a doctor.
 • Children under
   12 years:
Consult a doctor.

OTHER SAFETY INFORMATION

Other information:
read all warnings and directions before use. Keep
carton. Store at 20-25°C (68-77°F) avoid excessive
heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Hydroxypropyl Methylcellulose, Microcrystalline
Cellulose, Polyethylene Glycol, Povidone, Sodium
Starch Glycoate, Stearic Acid, Titanium Dioxide

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

100 TABLETS        Part # 547R23
PER BOX

Pain-Free® Extra Strength
Maximum Strength
Pain Reliever

Temporary relief of fever and
the pain of Sinusitis, headache,
toothache, muscular aches,
backache, menstrual discomfort,
minor arthritis pain and colds
and flu.

Compare active ingredient to:
EXCEDRIN Migraine®
Registered Trademark of GlaxoSmithKline


MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
(913) 269-9611

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

0560-2 100ct Box0560-2 100ct Box

250 Tablet Box

0560-3 250ct Box0560-3 250ct Box

2-Tablet Packet

0560 2ct Packet0560 2ct Packet

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN1
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD1
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81238-0560-22023-01-30C16284748780-1f386c64a-146f-0266-e053-dadaa90a7c1aAramark Pain-Free Extra Strength
81238-0560-32023-01-30C16284748780-1f386c64a-146f-0266-e053-dadaa90a7c1aAramark Pain-Free Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-0560-2Aramark Pain-Free Extra Strength50 in 1 BOXTABLET501
81238-0560-2Aramark Pain-Free Extra Strength2 in 1 PACKETTABLET21
81238-0560-3Aramark Pain-Free Extra Strength2 in 1 PACKETTABLET21
81238-0560-3Aramark Pain-Free Extra Strength125 in 1 BOXTABLET1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-0560ARAMARK PAIN-FREE EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WESTERN FIRST AID SAFETY DBA ARAMARK]1Legacy NDC, 4 package rows20210604_db07055e-9163-4fd8-b831-1a46599d4df4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81238-056081238-0560-2, 81238-0560-3

Ingredients#

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

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

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
e22342b7-9c6e-4642-a840-038448cf54aadb07055e-9163-4fd8-b831-1a46599d4df42021-06-03WarningsExact identifier
spl id: e22342b7-9c6e-4642-a840-038448cf54aa
spl set id: db07055e-9163-4fd8-b831-1a46599d4df4

Reported adverse events (FAERS/openFDA)#

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