Headache Relief Tablet, Coated
FDA Label NDC 0363-0770

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE (370R)

Active ingredient (in each caplet) Purpose
Acetaminophen 250 mg. . . . . . . . . . . . . . . . . . . . . . .Pain reliever
Aspirin 250 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever
Caffeine 65 mg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pain reliever aid

*nonsteroidal anti-inflammatory drug

Pain reliever

Pain reliever aid

Uses:
temporarily relieves minor aches and pains due to:

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps

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
• shock
• asthma (wheezing)


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

• skin reddening
• blisters
• rash

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


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

• more than 8 caplets 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 an 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 prescription or nonprescription NSAIDs (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 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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug or are under a doctor’s care for any serious condition

Stop using and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• you experience any of the following signs of stomach bleeding:

- feel faint

- have bloody or black stools

- vomit blood

- have stomach pain that does not get better

• ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients: carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

Questions or Comments?

call 1-877-290-4008