HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin 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:

Salado Sales, Inc.

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: headache a cold arthritis toothache muscular aches premenstrual and menstrual cramps - headache - a cold - arthritis - toothache - muscular aches - premenstrual and menstrual cramps

Authorization status:

OTC monograph not final

Summary of Product characteristics

HEADACHE RELIEF EXTRA STRENGTH- ACETAMINOPHEN, ASPIRIN AND
CAFFEINE TABLET, FILM COATED
SALADO SALES, INC.
_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._
----------
CVP 44-159B
_ACTIVE INGREDIENTS (IN EACH TABLET)_
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:
headache
a cold
arthritis
toothache
muscular aches
premenstrual and 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: Aspirin may cause a severe allergic reaction, which may
include:
hives
facial swelling
shock
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
more than 4,000 mg of acetaminophen in 24 hours
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
take more or for a longer time than directed
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
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
CAFFEINE WARNI