EXTRA STRENGTH HEADACHE RELIEF tablet, 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:

Healthlife of USA

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever, Pain reliever aid - Temporarily relieves minor aches and pains due to: - headache - a cold - arthritis - muscular aches - sinusitis  - toothache - premenstrual and menstrual cramps - if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/ fever reducer - with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure wheather a drug contains acetaminophen, ask a doctor or pharmacist. - you have liver disease - 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 have asthma - you are taking a diuretic - taking a prescription drug for diabetes, gout, or arthritis - taking any other drug or are under a doctor's care for any serious condition - you experience any of the following signs of stomach bleeding - feel faint - have bloody or black stools - vomit blood - have stomach pain that does no

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXTRA STRENGTH HEADACHE RELIEF- EXTRA STRENGTH HEADACHE RELIEF TABLET,
COATED
HEALTHLIFE OF USA
_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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EXTRA STRENGTH HEADACHE RELIEF
DRUG FACTS
PURPOSE
Pain reliever, Pain reliever aid
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen 250mg
Aspirin 250mg
Caffeine 65mg
USES
Temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
toothache
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 behaviour 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)
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take:
more than 8 Tablets in 24 hours, which is the maximum daily amount
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:
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
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, food, or
beverages while takin