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Extra Strength Pain Reliever Dailymed



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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

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

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


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 NovartisOwner of the registered trademark Excedrin®.

Product #1372

Extra StrengthPain 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 theworkplace and meet ANSI Z308. 1-2021 standards. They are sealed intamper-evident packets for safety and convenience.

50 Caplets • 2 Caplets Per Packet

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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