Formulation/Composition: Each teaspoon (5ml) contains 120 mg of paracetamol.

Indications: For the relief of headaches, minor aches and pains, and reduction of fever.

Contraindication(s): Paracetamol Syrup is contraindicated in patients with a known hypersensitivity

to acetaminophen (paracetamol). Long term use of acetaminophen (paracetamol)
patients with anemia or with cardiac, pulmonary, renal or hepatic disease is also
contraindicated.

Precaution(s): Paracetamol should be given with care to patients with impaired kidney or liver
function

Warning(s): If fever persists for more than 3 days (72 hours) or if pain continues for more
than
5 days, consult your physician.
As with any drug, if you are a pregnant or nursing a baby, seek medical advice of
Medical professional before using this product.

Interactions: Avoid alcohol while taking acetaminophen (paracetamol) as this may increase a
Acetaminophen-induced liver damage, anticonvulsant drugs, diflusinal, isoniazid,
aspirin, warfarin, cholysteramine, product containing acetaminophen
(paracetamol) and drugs that affect liver enzyme should be avoided.

Undesirable effects: Generally, side effects to acetaminophen (Paracetamol) are mild though
hematological reactions have been reported. Skin rashes and other allergic
reactions occur occasionally.

Overdose and Treatment: In any case of overdosage of acetaminophen (paracetamol), acetylcysteine should
be administered immediately if 24 hours or less have elapsed from the reported
time of ingestion. To be effective in protecting against sever liver damage,
therapy with acetylcysteine must be started within 10 hours of acetaminophen
(paracetamol) ingestion. There are some evidences of progressively diminished
efficiency thereafter, possibly lasting up to 12 to 16 hours.

It should be borne in mind that after a fatal dose of acetaminophen (paracetamol),

the patient may appear relatively well initially and may even continue normal
activities for a day or two before the onset hepatic failure.

The following procedure is recommended in treating acetaminophen

(paracetamol) overdosage:
1. The stomach should be emptied promptly by lavage or by inducing
emesis with syrup of ipecac. Syrup of ipecac should be given in a
dose of 15 to 30 ml for children and 30 to 45 ml for adults
 accompanied by drinking copious quantities of water. The dose
should be repeated if emesis does not occur in 20 minutes.
2. Draw blood for acetaminophen (paracetamol) plasma assay and for
baseline SGOT, SGPT, bilirubin, prothrombin time, creatinine,
BUN, blood sugar and electrolytes. The acetaminophen
(paracetamol) assay provides a reliable prognostic indication of
potential hepatoxicity and serves as a basis for determining the need
for continuing with the maintenance doses of acetylcystein treatment.
The laboratory measurements are used to monitor are used to
monitor hepatic and renal function and electrolyte and fluid balance.
3. The loading dose of acetylcysteine is 140 mg/kg of body weight. The
maintenance dose is 70mg/kg.
4. If the patient vomits the oral loading dose of any oral maintenance
dose within one hour of administration, repeat that dose.
5. If the patient is unable to retain orally administered acetylcysteine,
the antidote may be administered by duodenal intubation or by
intravenous route.
6. Repeat test for baseline SGOT, SGPT, bilirubin, prothrombin time,
creatinine, BUN, blood sugar and electrolytes daily. If
acetaminophen (paracetamol) plasma level is in the potentially toxic
range, Haemoperfusion may be worth while if too much time has
elapsed since the poisoning to allow use of acetylcysteine.

Storage conditions: Store at temperatures not exceeding 30°C. Protect from light.

Pack size or Net content: 120 mL

ADR Reporting Statement: For suspected adverse drug reactions, report to the FDA: www.fda.gov.ph

Seek medical attention immediately at the first sign of any adverse drug reaction.

Registration Number: AD-FD18976

Batch Number and Lot Number:3L7865

Expiration Date: APRIL 2022

Date of Manufacture: MARCH 2020