PAIN RELIEVER EXTRA STRENGTH- acetaminophen, aspirin, 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:

Rite Aid Corporation

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Pain reliever aid - temporarily relieves minor aches and pains due to: a cold toothache headache muscular aches premenstrual and menstrual cramps arthritis - a cold - toothache - headache - muscular aches - premenstrual and menstrual cramps - arthritis

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN RELIEVER EXTRA STRENGTH- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET,
FILM COATED
RITE AID CORPORATION
_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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RITE AID 44-334B - DELISTED
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever
Pain reliever
Pain reliever aid
_USES_
temporarily relieves minor aches and pains due to:
a cold
toothache
headache
muscular aches
premenstrual and menstrual cramps
arthritis
_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: Aspirin may cause a severe allergic reaction, which may
include:
shock
facial swelling
hives
asthma (wheezing)
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.
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if you take:
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
more than 4,000 mg in 24 hours, which is the maximum daily amount
STOMACH BLEEDING WARNING: This product contains an NSAID, which may
cause severe stomach
bleeding. The chance is higher if you:
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
are age 60 or older
take more or for a longer ti