EXCINOL MIGRAINE (ACETAMINOPHEN)- acetaminophen tablet, delayed release

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:

America Medic & Science, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Ultra relief Migraine pain - Relieves Migraine - if you have 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 whether a drug contains acetaminophen, ask a doctor or pharmacist - you have never had migraines diagnosed by a health professional - you have a headache that is different from your usual migraines - you have the worst headache of your life - you have fever and stiff neck - you have headaches beginning after or caused by head injury, exertion, coughing or bending - you experienced your first headache after the age of 50 - you have daily headaches - you have a migraine so severe as to require bed rest - 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 are taking a diuretic - you have asthma

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXCINOL MIGRAINE (ACETAMINOPHEN)- ACETAMINOPHEN TABLET, DELAYED
RELEASE
AMERICA MEDIC & SCIENCE, 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._
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EXCINOL MIGRAINE (ACETAMINOPHEN)250 MG
EXCINOL MIGRAINE (ACETAMINOPHEN)
250 MG
DRUG FACTS
ACTIVE INGREDIENT
Acetaminophen 250 mg
Aspirin 250 mg
Caffeine 65 mg
PURPOS E
Ultra relief Migraine pain
US ES
Relieves Migraine
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
asthma (wheezing)
shock
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, foods, or
beverages while taking this product
because too much caffeine may cause nervousness, irritability,
sleeplessness, and, occasionally, rapid
heart b