FDA Label for Tension Headache Aspirin Free

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg
(formulated with 65 mg caffeine)

Purpose

Pain reliever 

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches 
  
  

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• blisters
• rash
• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Caffeine warning: The recommended dose 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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

• new symptoms occur
• painful area is red or swollen
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

These could be signs of a serious condition. 

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-2222) 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

• do not use more than directed
  
• adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
• children under 12 years: ask a doctor

Other Information

• store at 25°C (77°); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number 

Inactive Ingredients

corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions Or Comments?

 1-800-426-9391

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♥ CVS Health™

Compare to the active ingredients
in Excedrin® Tension Headache*

Caplets

NDC 59779-824-08

Aspirin-Free
TENSION HEADACHE

ACETAMINOPHEN
& CAFFEINE
Pain reliever

24 CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by GSK group of companies,
owner of the registered trademark Excedrin® Tension Headache.
50844              ORG041742808

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