EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (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), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Pain reliever aid

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXCEDRIN EXTRA STRENGTH PAIN RELIEVER- 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 INGREDIENT (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_
•
_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:
•
temporarily relieves minor aches and pains due to:
o
o
o
o
o
o
headache
a cold
arthritis
muscular aches
toothache
premenstrual & menstrual cramps
skin reddening
•
•
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:
•
•
•
•
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take
•
•
•
STOMACH BLEEDING WARNING: This product contains an NSAID, which may
cause
severe stomach bleeding. The chance is higher if you
•
•
•
•
•
•
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
•
•
ASK A DOCTOR BEFORE USE IF
•
•
•
•
•
•
blisters
rash
hives
facial swelling
asthma (wheez