FDA Label for Acetaminophen, Aspirin And Caffeine

Do Not Use If Printed Seal Under Cap Is Missing Or Damagedread All Product Information Before Using. Keep Box For Important Information.Drug Facts

Active ingredients (in each tablet)                                                          Purposes
Acetaminophen USP, 250 mg...............................................................Pain reliever
Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever
Caffeine USP, 65 mg........................................................................Pain reliever aid
*nonsteroidal anti-inflammatory drug

Uses

• temporarily relieves minor aches and pains due to:
• headache 
• a cold
• arthritis 
• muscular aches
• toothache
• premenstrual & 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: 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.

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 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 heart beat.

Do Not Use

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1- 800-222-1222). 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: take 2 tablets with a glass of water
• if symptoms persist or worsen, ask your doctor 
• do not take more than 8 tablets in 24 hours, unless directed by a doctor
• under 18 years of age: ask a doctor

Other information

• store at controlled room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using.

Inactive Ingredients

Colloidal silicon dioxide , hypromellose, microcrystalline cellulose , polyethylene glycol, povidone, pregelatinized starch , sodium starch glycolate , stearic acid, talc

Package Label.Principal Display Panel

Acetaminophen, Aspirin (NSAID*) and Caffeine Tablets USP, 250mg/250mg/65mg

NDC 57237-348-01

100 Tablets

acetam-asp-caff-label - acetam asp caff label