EXCEDRIN EXTRA STRENGTH CAPLETS acetaminophen aspirin (nsaid) and caffeine tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 250 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXCEDRIN EXTRA STRENGTH CAPLETS- ACETAMINOPHEN, ASPIRIN (NSAID), AND
CAFFEINE TABLET, FILM COATED
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
_PURPOSES_
Pain reliever
Pain reliever
Pain reliever aid
_USES_
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_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:
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temporarily relieves minor aches and pains due to:
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headache
a cold
arthritis
muscular aches
toothache
premenstrual & menstrual cramps
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:
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LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if
you take
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STOMACH BLEEDING WARNING:
This product contains an NSAID, which may cause severe stomach
bleeding. The chance is higher if
you
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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
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ASK A DOCTOR BEFORE USE IF
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hives
facial swelling
asthma (whe