Extra Strength Pain Reliever

Manufacturer
JHK Inc dba American Safety & First Aid
Effective date
2024-04-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:11:26

Label at a glance#

ProductExtra Strength Pain Reliever
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections

Dosage and administration

2 tablets, with water every 6 hours while symptoms persist; not to exceed 8 tablets in 24 hours or as directed by a doctor. Children under 12 years: consult a doctor.

Storage and handling

do not use if packet is opened or torn store at room temperature 68º-77ºF (20º-25ºC) avoid excessive heat and humidity each caplet contains: Magnesium 0.58 mg

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (In Each Caplets)Purpose
Acetaminophen 250 mgpain reliever/fever reducer
Aspirin 250 mg (NSAID)* pain reliever/fever reducer
Caffeine 65 mgpain reliever aid

* Nonsteroidal Anti-Inflammatory Drug

Use

INDICATIONS & USAGE SECTION

temporarily relieves fever and minor aches and pains associated with:

  • headache
  • colds
  • muscular aches
  • menstrual discomfort
  • toothaches
  • minor arthritis pain

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

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

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets 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

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (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

Caffeine warning

SPL UNCLASSIFIED SECTION

The recommended dosage of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and, occasionally, rapid heartbeat.

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin
  • with any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to 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
  • with any other product containing acetaminophen (prescription or nonprescription).
  • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease
  • you are taking diuretic
  • you have a history of stomach problems, such as heartburn

OTC - ASK DOCTOR/PHARMACIST SECTION

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

  • anticoagulation (thinning of blood)
  • diabetes
  • gout
  • arthritis

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose.

OTC - STOP USE SECTION

Stop use and ask doctor if 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
  • 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 breastfeeding, 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.

Directions Adults

DOSAGE & ADMINISTRATION SECTION

2 tablets, with water every 6 hours while symptoms persist; not to exceed 8 tablets in 24 hours or as directed by a doctor. Children under 12 years: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • do not use if packet is opened or torn
  • store at room temperature 68º-77ºF (20º-25ºC)
  • avoid excessive heat and humidity
  • each caplet contains: Magnesium 0.58 mg

Inactive ingredient

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 46561

PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

This product is not manufactured or distributed by Novartis
Owner of the registered trademark Excedrin®.

Product #1372

Extra Strength
Pain Reliever

Pain Reliever/Fever Reducer

Active ingredient:
Acetaminophen, Aspirin
Caffeine

  • Temporary relief from pain, fever, and inflammation
  • Soothes muscle aches and minor arthritis pain

These quality comfort caplets are formulated and packaged for use in the
workplace and meet ANSI Z308. 1-2021 standards. They are sealed in
tamper-evident packets for safety and convenience.

50 Caplets • 2 Caplets Per Packet

PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box
PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box

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
73598-1372-12024-04-25C16284748780-11030e365-555b-111a-e063-dadaa90a10e2Extra Strength Pain Reliever
73598-1372-12024-01-30C16284748780-11030e365-555b-111a-e063-dadaa90a10e2Extra Strength Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1372-1Extra Strength Pain Reliever2 in 1 DOSE PACKCAPSULE, COATED22
73598-1372-1Extra Strength Pain Reliever25 in 1 BOXCAPSULE, COATED252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1372EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) CAPSULE, COATED [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240426_87c5ad71-0448-4e0f-acee-bf9a1d38675e.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
73598-137273598-1372-1

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
Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN, AND CAFFEINEJHK Inc dba American Safety & First Aid87c5ad71-0448-4e0f-acee-bf9a1d38675e2024-04-25WarningsExact identifier
ndc (package): 73598-1372-1
ndc (product): 73598-1372
ndc11 (package): 73598137201
spl id: 82d54d28-2fd1-44f4-ae89-5f23b79a37bd
spl set id: 87c5ad71-0448-4e0f-acee-bf9a1d38675e

Reported adverse events (FAERS/openFDA)#

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