BAYER HEADACHE RELIEF- aspirin and caffeine capsule

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:

Bayer HealthCare LLC

INN (International Name):

Aspirin

Composition:

Aspirin 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

for the temporary relief of - headache - muscle aches and pains

Authorization status:

OTC monograph final

Summary of Product characteristics

BAYER HEADACHE RELIEF- ASPIRIN AND CAFFEINE CAPSULE
BAYER HEALTHCARE 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._
----------
BAYER
HEADACHE
RELIEF
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH CAPLET)_
_PURPOSE_
*
Aspirin 500 mg (NSAID)
Pain reliever
Caffeine 32.5 mg
Pain reliever aid
US ES
for the temporary relief of
headache
muscle aches and pains
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
asthma (wheezing)
facial swelling
shock
STOMACH BLEEDING WARNING
This product contains an NSAID, which may cause severe stomach
bleeding. The chance is higher if
you
are age 60 or older
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
take more or for a longer time than directed
®
nonsteroidal anti-inflammatory drug
*
DO NOT USE if you are allergic to aspirin or any other pain
reliever/fever reducer
ASK A DOCTOR BEFORE USE IF
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or
kidney disease
you are taking a diuretic
you have asthma
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription
drug for
gout
diabetes
arthritis
STOP USE AND ASK A DOCTOR IF
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of