ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Granules India Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Pain reliever aid - treats migraine • 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 • you have never had migraines diagnosed by a health professional • you have a headache that is different from your usual migraines • you have the worst headache of your life • you have fever and stiff neck • you have headaches beginning after or caused by head injury, exertion, coughing or bending • you experienced your first headache after the age of 50 • you have daily headaches • you have a migraine so severe as to require bed rest • you have liver disease • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN, ASPIRIN AND CAFFEINE- ACETAMINOPHEN, ASPIRIN AND
CAFFEINE TABLET
GRANULES INDIA LTD
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ACETAMINOPHEN, ASPIRIN AND CAFFEINE TABLETS USP, 250 MG, 250 MG AND 65
MG
ACTIVE INGREDIENT(S)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
PURPOSE
Pain reliever
Pain reliever
Pain reliever aid
USE(S)
treats migraine
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 2 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
MEDICATION OVERUSE HEADACHE WARNING: Headaches may worsen if this
product is
used for 10 or more days per month
CAFFEINE WARNING: The recommended dose of this product contains about
as much
caffeine as a cup of coffee. Limit th