PARACETAMOL

ACETRA
500 mg Tablet
ANALGESIC / ANTYPYRETIC
FORMULATION:
Each tablet contains:
Acetaminophen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 mg
Starch Paste, 10 %. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61.75 mg
Lactose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 mg
Stearic Acid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.5 mg
Talc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43.25 mg
DESCRIPTION:
Paracetamol (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of action of is not known.
Paracetamol is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and
fevers.
INDICATION:
It temporarily relieves minor aches and pains due to headache, muscular aches, backache, common colds.
DOSAGE AND AMINISTRATION:
Adults and children 12 years and over is 500-1000mg every 4 to 6 hours as necessary, with a maximum of 4000mg in any
24 hour period.
Or as prescribed by the physician.
CONTRAINDICATION:
Paracetamol 500mg Tablets should not be given to children under 10 years of age. If you take more paracetamol than you
should: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much
paracetamol can cause delayed, serious liver damage.
PRECAUTION:
Talk to your doctor before taking more than one medicine that contains acetaminophen. Check with your doctor right away
if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual
tiredness or weakness; or yellow eyes or skin.
USE IN PREGNANCY:
Paracetamol has been used routinely during all stages of pregnancy to reduce a high temperature and for pain relief. But as
with any medicine taken during pregnancy, use paracetamol at the lowest effective dose. for the shortest possible time.
USE IN LACTATION:
Paracetamol can be taken since, only a small amount of drug will go into your breastmilk and it's unlikely to harm your
baby. Just take it for the shortest possible time and stick to the recommended dose.
ADVERSE REACTION:
The most commonly reported adverse reactions have included nausea, vomiting, constipation. Injection site pain and
injection site reaction have been reported with the IV product.
OVERDOSE AND TREATMENT:
An overdose of paracetamol can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4
grams (4000 mg) per day. Using more paracetamol could cause damage to your liver.
Treatment: Activated charcoal, acetylcysteine, liver transplant.
CAUTION:
Foods Drugs. Devices and Cosmetics Act prohibits dispensing without prescription.
"For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph." Seek medical attentionimmediately at the
first sign of any adverse drug reaction.
AVAILABILITY:
Paracetamol (ACETRA) (500mg): Box x 50 tablets
Paracetamol (ACETRA) (250mg/5 mL): Syrup x 60 mL
STORAGE CONDITION:
PROTECT FROM LIGHT AND STORE IN A COOL, DRY PLACE BELOW 25°C.
DATE OF AUTHORIZATION: October 5, 2020
PACKAGE INSERT DATE OF REVISION: November 5, 2020

Manufactured by the Distributed by:

Marketing Authorization Holder: CLAMPRS CORP.
SQUARE LABORATORIES, INC. 8100 Visayan Village, Tagum City
Mabini St, Tagum City