EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, and caffeine capsule, coated

Extra Strength Pain Reliever by

Drug Labeling and Warnings

Extra Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by JHK Inc dba American Safety & First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Use

temporarily relieves fever and minor aches and pains associated with:

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

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

• 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

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

• 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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen, aspirin, and caffeine capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1372
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	RECTANGLE	Size	18mm
Flavor		Imprint Code	S53
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-1372-1	25 in 1 BOX	02/02/2000
1		2 in 1 DOSE PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M013	02/02/2000

Labeler - JHK Inc dba American Safety & First Aid (867236309)