EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, and caffeine capsule, coated 
JHK Inc dba American Safety & First Aid

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Extra Strength Pain Reliever

Drug Facts

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

Use

temporarily relieves fever and minor aches and pains associated with:

Warnings

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

Aspirin may cause a severe allergic reaction which may include:

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

Liver Warning

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

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

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

  • 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

  • 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

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

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

When using this product do not exceed recommended dose.

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

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.

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

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

Inactive ingredient

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

Questions?

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

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

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
EXTRA STRENGTH PAIN RELIEVER 
acetaminophen, aspirin, and caffeine capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLESize18mm
FlavorImprint Code S53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73598-1372-125 in 1 BOX02/02/2000
12 in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01302/02/2000
Labeler - JHK Inc dba American Safety & First Aid (867236309)

Revised: 4/2024
Document Id: 82d54d28-2fd1-44f4-ae89-5f23b79a37bd
Set id: 87c5ad71-0448-4e0f-acee-bf9a1d38675e
Version: 2
Effective Time: 20240425
 
JHK Inc dba American Safety & First Aid