Aspirin chewable tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

acetylsalicylic acid

Available from:

Allegiant Health 75 North Industry Court

ATC code:

N02BA01

INN (International Name):

acetylsalicylic acid

Dosage:

81mg

Pharmaceutical form:

chewable tablets

Units in package:

(36) in plastic container

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-10-09

Patient Information leaflet

INFORMATION LEAFLET
Patient’s instructions for use of the medicinal product
ASPIRIN 81MG CHEWABLE TABLETS
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO USE IT CAREFULLY TO
GET THE BEST RESULTS FROM IT.

KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.

ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE.

IF YOUR CHILD GETS ANY SIDE EFFECTS, TALK TO YOUR CHILD’S DOCTOR OR
PHARMACIST. THIS
INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE
SECTION 4.

YOU MUST TALK TO A DOCTOR IF YOUR CHILD DOES NOT FEEL BETTER OR IF
YOUR CHILD FEELS
WORSE.
WHAT IS IN THIS LEAFLET:
1.
WHAT ASPIRIN 81MG CHEWABLE TABLETS ARE AND WHAT IT IS USED FOR
2.
WHAT YOU SHOULD KNOW BEFORE YOU USE ASPIRIN 81MG CHEWABLE TABLETS
3.
HOW TO TAKE ASPIRIN 81MG CHEWABLE TABLETS
4.
POSSIBLE ADVERSE REACTIONS
5.
HOW TO STORE ASPIRIN 81MG CHEWABLE TABLETS
6.
PACKAGE CONTENTS AND OTHER INFORMATION
1.
WHAT ASPIRIN IS AND WHAT IT IS USED FOR
Each chewable tablet contains:
Active ingredient: Aspirin 81 mg
_ _
Inactive ingredients_: _
_ _
corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor
(flavoring ingredients
approved for use in a regulation of FDA, modified food starch),
saccharin sodium
Aspirin (_Acetylsalicylic acid) _belongs to a group of medicine called
nonsteroidal anti-
inflammatory drug (NSAID).
It is used for the temporary relief of minor aches and pains or as
recommended by your Doctor.
Ask your doctor about other uses for 81 mg Orange Chewable Aspirin.
2.
WHAT YOU SHOULD KNOW BEFORE YOU USE ASPIRIN
DO NOT TAKE ASPIRIN

if you are allergic to aspirin or any other pain reliever/fever
reducer

this product for at least 7 days after tonsillectomy or oral surgery
unless
directed by a doctor

if you have ever had an allergic reaction to this product or any of
its
ingredients
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_REYE’S SYNDROME:_ Children and teenagers who have or are recovering
from chicken pox or flu-
like symptoms should not use this product. When

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aspirin 81mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
_Active ingredient:_ 81mg acetylsalicylic acid
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet:
81 mg: Round, orange color and favor, standard convex tablet, debossed
“AZ 013” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Temporary relief of minor aches and pains or as recommended by your
Doctor.
Other uses for 81 mg Orange Chewable Aspirin as recommended by your
Doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 16 years and over
_Temporary relief of minor aches and pains:_ The recommended dose is 4
to 8 tablets of Aspirin
81mg every 4 hours. Not to exceed 48 tablets in 24 hours unless
directed by a doctor
Method of administration
For oral use.
Preferably be taken after meals. Drink a full glass of water with each
dose
4.3
CONTRAINDICATIONS
DO NOT TAKE ASPIRIN

if you are allergic to aspirin or any other pain reliever/fever
reducer. Patients who are
hypersensitive to ASA, salicylates, non-steroidal anti-inflammatory
drugs (NSAIDs),
analgesics, antipyretics .

this product for at least 7 days after tonsillectomy or oral surgery
unless
directed by a doctor. Due to its inhibitory effect on platelet
aggregation which persists for
several days after administration, ASA may lead to an increased
bleeding tendency
during and after surgical operations (including minor surgeries, e.g.
dental extractions).

if you have ever had an allergic reaction to this product or any of
its
ingredients, or component of the container
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ _
_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 s