EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet, coated

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:

Spirit Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Pain reliever aid • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • sinusitis • toothache • premenstrual & menstrual cramps • 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 liver disease • 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 • you have asthma • any other drug containing an NSAID (prescription or non-prescription) • a prescription drug for diabetes, gout or arthritis • any other drug, or are under a doctor’s care for any serious condition • a blood thinning (anticoagulant) or steroid drug • an allergic reaction occurs. Seek medical help right away. • 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 • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • any new symptoms appear. These could be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXTRA STRENGTH HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, AND
CAFFEINE TABLET, COATED
SPIRIT PHARMACEUTICALS LLC
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EXTRA STRENGTH HEADACHE RELIEF
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
Acetaminophen
Aspirin
Caffeine
_PURPOSE_
Pain reliever
Pain reliever
Pain reliever aid
_USES_
• temporarily relieves minor aches and pains due to: • headache
• a cold • arthritis •
muscular aches • sinusitis • 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. 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 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 t