EXTRA STRENGTH BACK AND BODY- aspirin, caffeine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Walgreen Company

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever aid for the temporary relief of - backache pain - muscle aches and pains - minor aches and pains of arthritis

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXTRA STRENGTH BACK AND BODY- ASPIRIN, CAFFEINE TABLET, FILM COATED
WALGREEN COMPANY
_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._
----------
WALGREENS 44-413-DELISTED
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Aspirin 500 mg (NSAID)*
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever
Pain reliever aid
_USES_
for the temporary relief of
backache pain
muscle aches and pains
minor aches and pains of 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:
hives
shock
facial swelling
asthma (wheezing)
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
take a blood thinning (anticoagulant) or steroid drug
have 3 or more alcoholic drinks every day while using this product
are age 60 or older
have had stomach ulcers or bleeding problems
take other drugs containing prescription or nonprescription NSAIDs
[aspirin,
ibuprofen, naproxen, or others]
DO NOT USE
if you are allergic to aspirin or any other pain reliever/fever
reducer
if you have ever had an allergic reaction to this product or any of
its ingredients
ASK A DOCTOR BEFORE USE IF
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have asthma
you have high blood pressure, heart disease, liver cirrhosis, or
kidney disease
you are taking a diuretic
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug for
gout
diabetes
arthritis
ST