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HSA Approval

BAYER ASPIRIN TABLET 500 mg

SIN05362P

BAYER ASPIRIN TABLET 500 mg

BAYER ASPIRIN TABLET 500 mg

January 29, 1991

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantBAYER (SOUTH EAST ASIA) PTE LTD
Licence HolderBAYER (SOUTH EAST ASIA) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

TABLET

**Directions** Adults: Take 1–2 tablets every 4–8 hours, up to maximum of 6 tablets per 24 hours. Tablet should preferably be taken after meals, with plenty of liquid. Tablet maybe dissolved in water to facilitate intake. Do not exceed the stated dose. Not recommended to be taken by patients < 16 years old, unless directed by a doctor.

ORAL

Medical Information

**What is this medicine used for?** Bayer ASPIRIN may be used for short-term use in temporary relief of mild to moderate pain (headache, toothache, neuralgia, muscular aches and pain, pain associated with colds or influenza) and fever.

**Before you take this medicine** **DO NOT take this medicine if you:** - Are allergic to ASPIRIN (acetylsalicylic acid) or any other ingredients in this product. - Are allergic to any other pain-relieving or anti-inflammatory medicines (e.g. NSAIDs or salicylates, the class of substances to which acetylsalicylic acid belongs). - Are on high dose of methotrexate (15mg per week or more). If you are not sure, check with your doctor. - Are pregnant or breastfeeding, unless advised by a doctor. Do not take the medicine if you are in the last trimester of pregnancy. - Are taking other medicines, especially blood thinning agents, other painkillers or medicines used for arthritis, diabetes or gout, unless advised by a doctor. - Are about to have any surgery, including minor operations such as dental surgery. Always check with your physician first if you are unsure. Always inform the physician at least one week before the surgery that you are taking ASPIRIN. - Are below 16 years of age, unless advised by a doctor. There is a possible association or risk of Reye’s Syndrome (a rare but possibly life-threatening illness requiring immediate medical attention), when acetylsalicylic-containing products are given to children or adolescents for viral infections or chicken pox, with or without fever. - Have a disorder which causes a tendency to bleed, such as haemophilia. - Have severe heart, kidney or liver problems. - Have or had a history of stomach or duodenal ulcers, or gastro-intestinal bleeding, unless advised by a doctor. - Have asthma, hay fever, nasal polyps, chronic respiratory disease or other allergies that is worsened by ASPIRIN, salicylates or NSAIDs, unless advised by a doctor. - Have G6PD (glucose-6-phospate dehydrogenase) deficiency, unless advised by a doctor. - Are prone to having gout, unless advised by a doctor. At low doses, acetylsalicylic acid reduces the excretion of uric acid, and this may trigger a gout attack. Do not use continuously for more than 3 days without consulting a physician. If you are unsure whether you should take this medicine, consult your doctor or pharmacist.

N02BA01

acetylsalicylic acid

Manufacturer Information

BAYER (SOUTH EAST ASIA) PTE LTD

PT Bayer Indonesia

Bayer S.A.

Active Ingredients

ACETYLSALICYLIC ACID

500 mg

Aspirin

Documents

Patient Information Leaflets

Bayer Aspirin tablet PIL (Indonesia).pdf

Approved: March 10, 2020

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