ANACIN- asprin and caffeine tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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SPC SPC (SPC)
02-07-2020

active_ingredient:

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

MAH:

Insight Pharmaceuticals LLC

INN:

ASPIRIN

composition:

ASPIRIN 400 mg

administration_route:

ORAL

prescription_type:

OTC DRUG

therapeutic_indication:

Pain reliever Pain reliever aid temporarily relieves minor aches and pains due to - Headache - toothache - muscular aches - a cold - backache - arthritis - menstrual cramps

authorization_status:

OTC monograph not final

SPC

                                ANACIN- ASPRIN AND CAFFEINE TABLET
INSIGHT PHARMACEUTICALS 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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ANACIN - 63736-200
ANACIN- ASPRIN AND CAFFEINE TABLET INSIGHT PHARMACEUTICALS
ANACIN
_DRUG FACTS_
_ACTIVE INGREDIENTS (PER TABLET)_
Aspirin (NSAID)* 400 mg
Caffeine 32 mg
* nonsteroidal anti- inflammatory drug
_PURPOSES_
Pain reliever
Pain reliever aid
_USES_
temporarily relieves minor aches and pains due to
Headache
toothache
muscular aches
a cold
backache
arthritis
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
asthma (wheezing)
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 thinner (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
DO NOT USE
if you have ever had an allergic reaction to 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 diabetes, gout, or arthritis

                                
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